This is where you save and sustain lives.

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work positively impacts people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Together, we work at the critical intersection where innovations that save and sustain lives meet the physicians, nurses and pharmacists who make it happen.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and homes. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

For us, working at Baxter is not just a job—it’s a calling. Our mission to save and sustain lives unites us. No matter your role, your work positively impacts people around the world. When you join Baxter, you’ll feel a sense of pride, knowing your work improves the lives of millions. Your unique talents and a sense of purpose are what accelerate our mission.

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This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives&mdash;where your purpose accelerates our mission.
Summary
The Material Planner works to procure components in charge for the specific commodities assigned, necessary to provide continuity of shop floor activities to meet production plan scheduled in our Italian Plant.
#Thisiswhere you can develop your career path within Supply Chain in an international team!

Baxter


This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The Material Planner works to procure components in charge for the specific commodities assigned, necessary to provide continuity of shop floor activities to meet production plan scheduled in our Italian Plant.

#Thisiswhere you can develop your career path within Supply Chain in an international team!

Responsibilities


 - Analyze MRP inputs regularly as needed to assure right level of availability and inventory value

 - Release purchase orders for portfolio in charge to authorized suppliers, according to lead time and according to supplier quality agreement

 - Phase-in and phase-out components as part of the design change process

 - Analyze portfolio, setting right procurement parameters, safety stock in alignment to target inventory

 - Print orders, transmit to suppliers and fold them properly.

 - Close collaboration with suppliers, check deliveries dates according to purchase orders released.

 - Manage return of components hesitate negative.

 - Updated supplier data in the system, new supplier entering request, update parameters of purchase parts.

 - Implement KPI 's to monitor supplier’s performances and inventory levels.

 - Apply procedures and purchasing standard.


Qualifications


 - High school diploma or University Degree (better if in Management Engineering, Production Engineering or similar field) 

 - Previous experience in Supply Chain/Material Planning/Purchasing Operational

 - Fluent knowledge of English and Italian (written and spoken)

 - Excellent communication skills and strong orientation to interpersonal relationships

 - Critical sense and organizational skills

 - Ability to work in team


Active

Material Planner

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives&mdash;where your purpose accelerates our mission.


This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Responsibilities


 - Reviews and evaluates complaints, participates in the evaluation and analysis of risks associated with reported incidents

 - Identifies and reports patient safety issues to his/her management 

 - Ensures communication with the departments concerned within the production department 

 - Ensures that complaints concerning suppliers are forwarded to them  

 - Participates in the research of industrial traceability data and verifies the investigations carried out (confirmation of anomalies, determination of causes and potential impacts) in order to prepare the claim closure file 

 - Ensures regulatory compliance of the claims file  

 - Takes charge of and prepares responses to requests from health authorities 

 - Monitors and updates trend analyses related to complaints in order to identify whether follow-up in another quality system (NCR/CAPA, FA, etc.) is necessary. Ensures the transition to the other identified quality system elements

 - Carries out trend analyses following specific requests from other departments 

 - Ensures the updating of global complaint indicators and reporting to management 

 - Participates in the sensitization/training of production personnel in relation to reported incidents 


Qualifications


 - Master/scientific or engineer degree

 - Experience in the medical or pharmaceutical industry in a Quality Assurance and/or Customer Complaint Management department 

 - Professional English (read/written/spoken) and fluent French 

 - Computer skills: MS office / databases/Excel advanced 

 - Ability to work in a team 

 - Analytical and structured way of thinking 

 - Solution-oriented way of working 


Quality Assurance Complaints Engineer

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives&mdash;where your purpose accelerates our mission.
Summary
The SPO Specialist will provide clinical expertise across the acute therapy portfolio via development and review of various documents describing the clinical use of the products and benefit and risk of the products. As a healthcare company Baxter is required to develop and submit various regulatory and safety document to regulators around the works. This position will create and/or review various documents such as annual reports for acute therapy products, risk management plans, and changes to documents related to manufacturing and design changes. This person will work with cross functional teams globally: including individuals within Clinical Operations, HEOR, Medical, Quality, Regulatory and Patient Safety departments.
Essential Duties and Responsibilities
<ul>
<li>
Provide medical/clinical expertise related to acute therapies and related products including their clinical use and potential misuse to internal cross function teams
</li>
<li>
Prepare clinical response to government authorities, in conjunction with regulatory to ensure questions around acute therapies are interpreted correctly
</li>
<li>
Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and/or summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include Investigator brochures, clinical study reports, integrated reports, clinical investigation reports, new product submissions. May also include review of case reports and statistical analysis plans, product labels, and response to regulatory agency inquiries.
</li>
<li>
Maintain current familiarity with the published medical literature related to acute therapy product lines so that information can be incorporated onto various documents created with the organization in compliance with regulations around the world.
</li>
<li>
Possess an understating and maintain current knowledge of regulatory and quality requirements.
</li>
<li>
Develop/review annual safety documents (such as PBRER, PSUR, CER, RMP&rsquo;s) and labelling products.
</li>
<li>
Responsible for coordination, preparation, and/or completion of clinical sections of acute therapy related risk file updates, CCSI or label updates, and other documents as assigned.
</li>
<li>
Develop and review quality related documents as they pertain to acute therapy products.
</li>
<li>
Provide clinical support of complaint and adverse event analyses.
</li>
<li>
Assist Baxter Regulatory Affairs by providing clinical input in to evaluation and response of Ministry of Health (MOH) queries.
</li>
<li>
Develop expert knowledge of all Baxter Acute therapy products.
</li>
<li>
Interface with other Baxter function groups such as Clinical, HEOR, Regulatory Affairs, Quality and global business units, as needed.
</li>
<li>
Work with the team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted ion time to regulatory authorities.
</li>
<li>
Lead or participate in team projects and committees as assigned.
</li>
<li>
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable). Includes collaborating with appropriate personnel to ensure documents are publication-ready across the functional teams.
</li>
</ul>
Qualifications:
The Medical Writer must demonstrate:
<ul>
<li>
Experience in scientific and/or medical writing
</li>
<li>
Experience in the analytical evaluation of scientific data
</li>
<li>
Strong organizational skills and meticulous attention to detail
</li>
<li>
Familiarity with clinical trial-related and regulatory clinical submission templates
</li>
</ul>
The Medical Writer must be able to:
<ul>
<li>
Apply global regulatory authority regulations and/or guidance
</li>
<li>
Manage multiple projects with competing priorities
</li>
<li>
Work in a team environment
</li>
<li>
Demonstrate good communication skills
</li>
</ul>
The Medical Writer also should possess knowledge of computer software Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus.
Education and/or Experience:
The Medical Writer must have a BS or MS in scientific discipline&nbsp;(Biology, Biochemistry, Chemistry) with excellent writing skills.
At least 2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to&nbsp;Americas_TTA@baxter.com&nbsp;and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our&nbsp;<a href="https://jobs.baxter.com/how-to-apply#fraud-notice" target="_blank" rel="noopener">Recruitment Fraud Notice</a>.


This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The SPO Specialist will provide clinical expertise across the acute therapy portfolio via development and review of various documents describing the clinical use of the products and benefit and risk of the products. As a healthcare company Baxter is required to develop and submit various regulatory and safety document to regulators around the works. This position will create and/or review various documents such as annual reports for acute therapy products, risk management plans, and changes to documents related to manufacturing and design changes. This person will work with cross functional teams globally: including individuals within Clinical Operations, HEOR, Medical, Quality, Regulatory and Patient Safety departments.

Essential Duties and Responsibilities


 - 

Provide medical/clinical expertise related to acute therapies and related products including their clinical use and potential misuse to internal cross function teams


 - 

Prepare clinical response to government authorities, in conjunction with regulatory to ensure questions around acute therapies are interpreted correctly


 - 

Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and/or summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include Investigator brochures, clinical study reports, integrated reports, clinical investigation reports, new product submissions. May also include review of case reports and statistical analysis plans, product labels, and response to regulatory agency inquiries.


 - 

Maintain current familiarity with the published medical literature related to acute therapy product lines so that information can be incorporated onto various documents created with the organization in compliance with regulations around the world.


 - 

Possess an understating and maintain current knowledge of regulatory and quality requirements.


 - 

Develop/review annual safety documents (such as PBRER, PSUR, CER, RMP’s) and labelling products.


 - 

Responsible for coordination, preparation, and/or completion of clinical sections of acute therapy related risk file updates, CCSI or label updates, and other documents as assigned.


 - 

Develop and review quality related documents as they pertain to acute therapy products.


 - 

Provide clinical support of complaint and adverse event analyses.


 - 

Assist Baxter Regulatory Affairs by providing clinical input in to evaluation and response of Ministry of Health (MOH) queries.


 - 

Develop expert knowledge of all Baxter Acute therapy products.


 - 

Interface with other Baxter function groups such as Clinical, HEOR, Regulatory Affairs, Quality and global business units, as needed.


 - 

Work with the team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted ion time to regulatory authorities.


 - 

Lead or participate in team projects and committees as assigned.


 - 

Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable). Includes collaborating with appropriate personnel to ensure documents are publication-ready across the functional teams.



Qualifications:

The Medical Writer must demonstrate:


 - 

Experience in scientific and/or medical writing


 - 

Experience in the analytical evaluation of scientific data


 - 

Strong organizational skills and meticulous attention to detail


 - 

Familiarity with clinical trial-related and regulatory clinical submission templates



The Medical Writer must be able to:


 - 

Apply global regulatory authority regulations and/or guidance


 - 

Manage multiple projects with competing priorities


 - 

Work in a team environment


 - 

Demonstrate good communication skills



The Medical Writer also should possess knowledge of computer software Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus.

Education and/or Experience:

The Medical Writer must have a BS or MS in scientific discipline
(Biology, Biochemistry, Chemistry) with excellent writing skills.

At least 2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to
Americas_TTA@baxter.com
and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our
Recruitment Fraud Notice.

Medical Writer

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives&mdash;where your purpose accelerates our mission.
For us, working at Baxter is not just a job&mdash;it&rsquo;s a calling. Our mission to save and sustain lives unites us. Thank you for contributing your talent to make a positive impact on millions of people around the world.&nbsp;
We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.
We&rsquo;re grateful you&rsquo;re interested in continuing your career journey with Baxter. This is where you can do your best work. Where your purpose accelerates our mission.
Position Summary
Join Baxter in our mission to save and sustain lives by playing an integral role by being part of a global team that is revolutionizing the way we view our manufacturing processes.&nbsp;&nbsp; As part of the Digital Transformation organization, our team is responsible for deploying edge analytics platforms that use advanced statistical methods to monitor critical manufacturing processes in real time. &nbsp;&nbsp;As part of this team, you will help enable plants globally with long term sustainability, training, method development, new process identification, technology development and more.&nbsp; Plan, execute and participate in critical engineering assignments by applying your knowledge and skills in a regulated environment.
Essential Duties and Responsibilities
<ul>
<li>Develop and test models using various processing methods to assess feasibility, operating condition effects, possible new applications, and necessity of modification.</li>
<li>The ability to plan, lead and facilitate training sessions on a global scale</li>
<li>The ability to work with minimal supervision for projects related to continuous improvement</li>
<li>Investigate potential new applications related to Multivariate Data Analysis, Machine learning, AI, Chemometrics</li>
<li>Willingness to travel for training sessions/MVDA applications at manufacturing facilities</li>
<li>Applies state of the art techniques in expertise to develop new or improved processes.</li>
<li>Support multiple projects globally</li>
<li>Troubleshoot issues with production equipment hardware and software.</li>
<li>Act as SME for new and existing technologies used throughout the network</li>
<li>Participate in cross-functional teams in detailed phases of the engineering work in a project.</li>
<li>Resolve issues related to projects and minimize delays or unexpected cost increases.</li>
<li>Able to work flexible hours as needed to support manufacturing activities.</li>
<li>Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)</li>
</ul>
Knowledge, Skill and Abilities
<ul>
<li>Ability to multi-task project responsibilities along with day-to-day activities.</li>
<li>Successful track record of managing activities related to large projects and production support.</li>
<li>Experience with data integrity requirements.</li>
<li>Ability to organize and present technical and project management overviews without assistance.</li>
<li>Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.</li>
<li>Must have excellent English written and oral communication skills adequate to communicate with other team members.</li>
</ul>
Education and/or Experience
<ul>
<li>B.S. in scientific discipline (Engineering, Data Science, Computer Science, Chemometrics) and 5 or more years related experience.</li>
<li>Experience in manufacturing process improvement, electromechanical machine design or process systems design is preferred.</li>
<li>Digitalization process qualification and troubleshooting experiences are desired.</li>
<li>Quality Engineering background (i.e. knowledge of quality systems, validation, etc.) will be given preference.</li>
<li>Knowledge of engineering/statistical tools (Design of Experiments, MVDA, Statistical Control, etc.)</li>
<li>Programming experience with Python using advanced statistical methods (ML/AI) will also be given preference</li>
<li>Good understanding of GxP, as well as Quality by Design (QbD) principles</li>
<li>Excellent in writing and oral communication in English, adequate computer skills</li>
<li>Well experienced in prioritizing multiple tasks in a fast-paced environment, demonstrate flexibility and the ability to shift gears between projects comfortably</li>
<li>Ability to work effectively in a matrix organization, and good communication and interpersonal skills are highly desirable</li>
<li>Be able to travel for assignments up to 30% time.</li>
</ul>
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to&nbsp;Americas_TTA@baxter.com&nbsp;and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our&nbsp;<a href="https://jobs.baxter.com/how-to-apply#fraud-notice" target="_blank" rel="noopener">Recruitment Fraud Notice</a>.
085485


This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

For us, working at Baxter is not just a job—it’s a calling. Our mission to save and sustain lives unites us. Thank you for contributing your talent to make a positive impact on millions of people around the world.


We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.

We’re grateful you’re interested in continuing your career journey with Baxter. This is where you can do your best work. Where your purpose accelerates our mission.

Position Summary

Join Baxter in our mission to save and sustain lives by playing an integral role by being part of a global team that is revolutionizing the way we view our manufacturing processes.

 As part of the Digital Transformation organization, our team is responsible for deploying edge analytics platforms that use advanced statistical methods to monitor critical manufacturing processes in real time. 

As part of this team, you will help enable plants globally with long term sustainability, training, method development, new process identification, technology development and more.
 Plan, execute and participate in critical engineering assignments by applying your knowledge and skills in a regulated environment.

Essential Duties and Responsibilities


 - Develop and test models using various processing methods to assess feasibility, operating condition effects, possible new applications, and necessity of modification.

 - The ability to plan, lead and facilitate training sessions on a global scale

 - The ability to work with minimal supervision for projects related to continuous improvement

 - Investigate potential new applications related to Multivariate Data Analysis, Machine learning, AI, Chemometrics

 - Willingness to travel for training sessions/MVDA applications at manufacturing facilities

 - Applies state of the art techniques in expertise to develop new or improved processes.

 - Support multiple projects globally

 - Troubleshoot issues with production equipment hardware and software.

 - Act as SME for new and existing technologies used throughout the network

 - Participate in cross-functional teams in detailed phases of the engineering work in a project.

 - Resolve issues related to projects and minimize delays or unexpected cost increases.

 - Able to work flexible hours as needed to support manufacturing activities.

 - Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)


Knowledge, Skill and Abilities


 - Ability to multi-task project responsibilities along with day-to-day activities.

 - Successful track record of managing activities related to large projects and production support.

 - Experience with data integrity requirements.

 - Ability to organize and present technical and project management overviews without assistance.

 - Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.

 - Must have excellent English written and oral communication skills adequate to communicate with other team members.


Education and/or Experience


 - B.S. in scientific discipline (Engineering, Data Science, Computer Science, Chemometrics) and 5 or more years related experience.

 - Experience in manufacturing process improvement, electromechanical machine design or process systems design is preferred.

 - Digitalization process qualification and troubleshooting experiences are desired.

 - Quality Engineering background (i.e. knowledge of quality systems, validation, etc.) will be given preference.

 - Knowledge of engineering/statistical tools (Design of Experiments, MVDA, Statistical Control, etc.)

 - Programming experience with Python using advanced statistical methods (ML/AI) will also be given preference

 - Good understanding of GxP, as well as Quality by Design (QbD) principles

 - Excellent in writing and oral communication in English, adequate computer skills

 - Well experienced in prioritizing multiple tasks in a fast-paced environment, demonstrate flexibility and the ability to shift gears between projects comfortably

 - Ability to work effectively in a matrix organization, and good communication and interpersonal skills are highly desirable

 - Be able to travel for assignments up to 30% time.


Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to
Americas_TTA@baxter.com
and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our
Recruitment Fraud Notice.

085485

Sr. Engineer, Global Operations Engineer

Latest jobs

We are looking for talented Supply Chain Co-Ordinator, who will execute the finished goods planning for our Plant in Malta and Tunsia.
This role will be responsible for coordinating the local planning activities with all departments, working closely with the Manufacturing, Warehousing Teams &amp; Regional Network Planners ensuring high level capacity plans are translated into workable production programmes, inventory projections are reviewed to ensure a seamless supply of product to the customer.
The Supply Chain Planner will:
<ul>
<li>Deliver to Manufacturing a programme aligned to capacity</li>
<li>Co-ordinate &amp; manage the stock levels/inventory of the manufactured and raw material products in an onsite and offsite warehouse</li>
<li>Proactively communicate and manage any gaps in or risk to supply</li>
<li>Responsible for the export of product to other Global plants</li>
<li>Utilize and correctly apply all of the standard Supply Chain tools and processes</li>
</ul>
Essential Duties and Responsibilities
<ul>
<li>Reviewing the raw material pipeline and ensuring supply is aligned to the manufacturing capacity</li>
<li>Utilizes pipeline management tools and ERP&rsquo;s to control and analyses pipeline</li>
<li>Uses their experience to define solutions/recommendations to solve issues</li>
<li>Has an excellent working relationship with local stakeholders to help them manage the pipeline;</li>
</ul>
<ul>
<li>Local plant manufacturing, warehouse, quality, logistics execution teams</li>
<li>EMEA SC execution team to manage bottlenecks in replenishment centers for inbound FG&rsquo;s</li>
</ul>
<ul>
<li>Proactively communicates any potential &amp; known supply risks to internal stakeholders, taking ownership and accountability for managing effective communication &amp; escalating when needed. Align and communicate with drivers and distribution centers to ensure efficient delivery of products.</li>
<li>Obtaining, checking, and preparing documentation to meet customs and insurance requirements, packing specifications, and compliance with other countries' regulations and fiscal regimes</li>
<li>Organize transportation activities, including storage of goods, managing information accrued from point of origin to delivery, orchestrating transportation movements, and arranging for services as necessary</li>
<li>Monitoring quality control and keeping warehouse capacity at optimal levels</li>
<li>Actively participate in Baxter Tier Boards and reporting KPIs at various levels</li>
<li>Owning and managing the supply chain elements with the change management( Change Control) ERP Trackwise 8</li>
</ul>
Fundamental requirements/experience:
<ul>
<li>Thrive in a dynamic and constantly changing environment</li>
<li>Able to influence the team through clear fact-based communication</li>
<li>Feel confident in pushing back on other functions and highlighting issues that could impact them</li>
<li>Simplify the Complex in every aspect of their work</li>
<li>Organizational and planning skills</li>
<li>teamwork, tact and good interpersonal skills</li>
<li>Show clear potential for development into point of contact for Liverpool site planning.</li>
<li>Excellent knowledge of Microsoft Office Programs especially Excel</li>
<li>sound industry knowledge</li>
<li>flexibility and the ability to adapt to changing circumstances</li>
<li>problem-solving ability, particularly when working under pressure</li>
<li>Good knowledge of manufacturing processes and systems</li>
<li>Strong Analytical Skills and high numerical</li>
<li>Capable of working under pressure and to deadlines</li>
<li>Self-disciplined to work under their own initiative</li>
<li>A strong Supply Chain Planning, Logistics &amp; Manufacturing background</li>
<li>APICS certification would be an advantage.</li>
<li>Supply Chain ERP knowledge of Rapid Response, JDE, SAP or equivalent.</li>
<li>Experience in Healthcare Manufacturing or similar fast-moving goods is advantageous</li>
<li>An understanding of 6S / Lean / Six Sigma.</li>
<li>Related work experience such as Planning, Logistics and Warehousing..</li>
</ul>


We are looking for talented Supply Chain Co-Ordinator, who will execute the finished goods planning for our Plant in Malta and Tunsia.

This role will be responsible for coordinating the local planning activities with all departments, working closely with the Manufacturing, Warehousing Teams &amp; Regional Network Planners ensuring high level capacity plans are translated into workable production programmes, inventory projections are reviewed to ensure a seamless supply of product to the customer.

The Supply Chain Planner will:


 - Deliver to Manufacturing a programme aligned to capacity

 - Co-ordinate &amp; manage the stock levels/inventory of the manufactured and raw material products in an onsite and offsite warehouse

 - Proactively communicate and manage any gaps in or risk to supply

 - Responsible for the export of product to other Global plants

 - Utilize and correctly apply all of the standard Supply Chain tools and processes


Essential Duties and Responsibilities


 - Reviewing the raw material pipeline and ensuring supply is aligned to the manufacturing capacity

 - Utilizes pipeline management tools and ERP’s to control and analyses pipeline

 - Uses their experience to define solutions/recommendations to solve issues

 - Has an excellent working relationship with local stakeholders to help them manage the pipeline;



 - Local plant manufacturing, warehouse, quality, logistics execution teams

 - EMEA SC execution team to manage bottlenecks in replenishment centers for inbound FG’s



 - Proactively communicates any potential &amp; known supply risks to internal stakeholders, taking ownership and accountability for managing effective communication &amp; escalating when needed. Align and communicate with drivers and distribution centers to ensure efficient delivery of products.

 - Obtaining, checking, and preparing documentation to meet customs and insurance requirements, packing specifications, and compliance with other countries' regulations and fiscal regimes

 - Organize transportation activities, including storage of goods, managing information accrued from point of origin to delivery, orchestrating transportation movements, and arranging for services as necessary

 - Monitoring quality control and keeping warehouse capacity at optimal levels

 - Actively participate in Baxter Tier Boards and reporting KPIs at various levels

 - Owning and managing the supply chain elements with the change management( Change Control) ERP Trackwise 8


Fundamental requirements/experience:


 - Thrive in a dynamic and constantly changing environment

 - Able to influence the team through clear fact-based communication

 - Feel confident in pushing back on other functions and highlighting issues that could impact them

 - Simplify the Complex in every aspect of their work

 - Organizational and planning skills

 - teamwork, tact and good interpersonal skills

 - Show clear potential for development into point of contact for Liverpool site planning.

 - Excellent knowledge of Microsoft Office Programs especially Excel

 - sound industry knowledge

 - flexibility and the ability to adapt to changing circumstances

 - problem-solving ability, particularly when working under pressure

 - Good knowledge of manufacturing processes and systems

 - Strong Analytical Skills and high numerical

 - Capable of working under pressure and to deadlines

 - Self-disciplined to work under their own initiative

 - A strong Supply Chain Planning, Logistics &amp; Manufacturing background

 - APICS certification would be an advantage.

 - Supply Chain ERP knowledge of Rapid Response, JDE, SAP or equivalent.

 - Experience in Healthcare Manufacturing or similar fast-moving goods is advantageous

 - An understanding of 6S / Lean / Six Sigma.

 - Related work experience such as Planning, Logistics and Warehousing..


Planner, Supply Chain

We are looking for Validation Engineer for our engineering team in Malta.
The Validation engineer is responsible for elements at the Liverpool Manufacturing Site. This position will work closely with the QA, Laboratory and Engineering and Production teams to assure validation is are effectively completed and maintained to ensure compliance with Regulatory and Baxter Corporate requirements. The Validation Engineer will report to the Validation Manager.
Essential duties:
<ul>
<li>
Writing validation protocols associated with equipment, analytical methods and CSV
</li>
<li>
Working with engineering projects to scope out the validation requirements of new projects
</li>
<li>
SME for Computer systems integrity
</li>
<li>
Act as a coach for validation activities
</li>
<li>
Partaking in the site processes for&nbsp;Global Observation Certifications,&nbsp;Internal Audit program, investigations inc. NCR and CAPA
</li>
<li>
Implement leading validation indicators and continuous improvement of the validation process
</li>
<li>
Undertake the following quality system roles (including access to the relevant system):&nbsp;NCR/CAPA, Change control, Document.
</li>
</ul>
Fundamental requirements:
<ul>
<li>
Knowledge and application of validation techniques
</li>
<li>
Applies analytical skills and knowledge of data analysis tools and methodologies
</li>
<li>
Experience in validation of Computer systems
</li>
<li>
Excellent written and spoken English
</li>
</ul>


We are looking for Validation Engineer for our engineering team in Malta.

The Validation engineer is responsible for elements at the Liverpool Manufacturing Site. This position will work closely with the QA, Laboratory and Engineering and Production teams to assure validation is are effectively completed and maintained to ensure compliance with Regulatory and Baxter Corporate requirements. The Validation Engineer will report to the Validation Manager.

Essential duties:


 - 

Writing validation protocols associated with equipment, analytical methods and CSV


 - 

Working with engineering projects to scope out the validation requirements of new projects


 - 

SME for Computer systems integrity


 - 

Act as a coach for validation activities


 - 

Partaking in the site processes for
Global Observation Certifications,
Internal Audit program, investigations inc. NCR and CAPA


 - 

Implement leading validation indicators and continuous improvement of the validation process


 - 

Undertake the following quality system roles (including access to the relevant system):
NCR/CAPA, Change control, Document.



Fundamental requirements:


 - 

Knowledge and application of validation techniques


 - 

Applies analytical skills and knowledge of data analysis tools and methodologies


 - 

Experience in validation of Computer systems


 - 

Excellent written and spoken English



Validation Engineer

The Documentation Technician belongs to the Quality Systems department and reports to the manager responsible for this area.
Their tasks are related to the maintenance of the documentation system as well as performing and supervising administrative tasks.
Essential Duties and Responsibilities
<ul>
<li>Maintain the documentation system of the plant, manage document change control, database, documentation file and distribution thereof</li>
<li>Prepare new designs or modifications of printed material according to the indications of RA and Marketing of the different countries of commercialization, keep all the documentation related to the change on file and distribute it</li>
<li>Comply with the standards of the NCF/GMP quality system, as well as the regulations of data integrity</li>
<li>Generate and/or update the base lists (BOM), review specifications and documentation received from the EMA (Artwork Design Centre)</li>
<li>Maintain the system regarding the destruction of raw materials (Management of rejected material)</li>
<li>Execute and maintain the customer satisfaction program</li>
<li>Maintain the process change control system and test management</li>
<li>Responsible for the custody of obsolete documents in accordance with the requirements of the system</li>
<li>Custody and filing of legal documents related to the quality system</li>
<li>Represent the plant in Baxter projects related to their area or sponsored by Quality System</li>
<li>Represent their area in internal projects for which they are designated</li>
<li>Maintain and update the indicators of their processes, communicating them at the required level in each case</li>
<li>Maintain and update the systems assigned to the Quality System area</li>
<li>Comply/ensure compliance with the General EHS Standards established in the company and specific to the Section. Legal requirements, Baxter requirements, and regulations (ISO and OSHAS)</li>
</ul>
Qualifications and Experience
<ul>
<li>Degree in training related field (preferably technical)</li>
<li>User-level knowledge of office automation and specific programs according to their training and authorizations</li>
<li>Knowledge of GMP quality system</li>
<li>Knowledge of internal and corporate procedures</li>
<li>Advanced level of English, Spanish is highly valued</li>
<li>Experience in quality system and as a quality auditor will be valued</li>
<li>High levels of accuracy and attention to detail</li>
</ul>


The Documentation Technician belongs to the Quality Systems department and reports to the manager responsible for this area.

Their tasks are related to the maintenance of the documentation system as well as performing and supervising administrative tasks.

Essential Duties and Responsibilities


 - Maintain the documentation system of the plant, manage document change control, database, documentation file and distribution thereof

 - Prepare new designs or modifications of printed material according to the indications of RA and Marketing of the different countries of commercialization, keep all the documentation related to the change on file and distribute it

 - Comply with the standards of the NCF/GMP quality system, as well as the regulations of data integrity

 - Generate and/or update the base lists (BOM), review specifications and documentation received from the EMA (Artwork Design Centre)

 - Maintain the system regarding the destruction of raw materials (Management of rejected material)

 - Execute and maintain the customer satisfaction program

 - Maintain the process change control system and test management

 - Responsible for the custody of obsolete documents in accordance with the requirements of the system

 - Custody and filing of legal documents related to the quality system

 - Represent the plant in Baxter projects related to their area or sponsored by Quality System

 - Represent their area in internal projects for which they are designated

 - Maintain and update the indicators of their processes, communicating them at the required level in each case

 - Maintain and update the systems assigned to the Quality System area

 - Comply/ensure compliance with the General EHS Standards established in the company and specific to the Section. Legal requirements, Baxter requirements, and regulations (ISO and OSHAS)


Qualifications and Experience


 - Degree in training related field (preferably technical)

 - User-level knowledge of office automation and specific programs according to their training and authorizations

 - Knowledge of GMP quality system

 - Knowledge of internal and corporate procedures

 - Advanced level of English, Spanish is highly valued

 - Experience in quality system and as a quality auditor will be valued

 - High levels of accuracy and attention to detail


Documentation Technician

Responsibilities
The Quality Assurance Engineer is primarily responsible for processing non-conformance reports (NCRs) and corrective and preventive actions (CAPAs) in the TrackWise system.
<ul>
<li>
Processing of NCR/CAPA records as owner and approver&nbsp;
</li>
<li>
Support all functions/areas in handling and documenting in TrackWise (quality management system)
</li>
<li>
Process optimizations, implementations and maintenance regarding NCR/CAPA&nbsp;
</li>
<li>
Participation in internal and external audits&nbsp;
</li>
<li>
Creation of records for the batch release&nbsp;
</li>
</ul>
Qualifications
<ul>
<li>
Completed university education or completed vocational or professional education with at least 3 years of professional experience in the field of medical devices or quality management&nbsp;
</li>
<li>
Secure knowledge of German (fluent) and English&nbsp;
</li>
<li>
Experience with databases - preferably "TrackWise"
</li>
<li>
Confident use of MS Office&nbsp;
</li>
<li>
Ability to work in a team&nbsp;
</li>
<li>
Analytical and structured way of thinking&nbsp;
</li>
<li>
Solution-oriented way of working&nbsp;
</li>
</ul>


Responsibilities

The Quality Assurance Engineer is primarily responsible for processing non-conformance reports (NCRs) and corrective and preventive actions (CAPAs) in the TrackWise system.


 - 

Processing of NCR/CAPA records as owner and approver



 - 

Support all functions/areas in handling and documenting in TrackWise (quality management system)


 - 

Process optimizations, implementations and maintenance regarding NCR/CAPA



 - 

Participation in internal and external audits



 - 

Creation of records for the batch release




Qualifications


 - 

Completed university education or completed vocational or professional education with at least 3 years of professional experience in the field of medical devices or quality management



 - 

Secure knowledge of German (fluent) and English



 - 

Experience with databases - preferably "TrackWise"


 - 

Confident use of MS Office



 - 

Ability to work in a team



 - 

Analytical and structured way of thinking



 - 

Solution-oriented way of working




QA Engineer – NCR/CAPA/Complaints

The Validation Technician monitors the validation plan and oversees the validation management computer system (eVMP), from the assignment of codes to their final file. They are also responsible for autoclave and for creating all types of validation documents.
Essential Duties and Responsibilities
<ul>
<li>Monitoring of the Validation Master Plan and overseeing the validation management computer system (eVMP) and validation documents, from the assignment of codes to their final file</li>
<li>Collaborate with the owners of the systems, advising them on the tasks to be carried out to ensure the maintenance of their validation status</li>
<li>Carry out all kinds of validation documents and follow up on the execution of the validation tests</li>
<li>Prepare protocols and reports for autoclave validations</li>
<li>Collaborate in improvement projects and new facilities, collaborating with the staff of other departments for their validation</li>
<li>Write and review procedures applicable to the validation area (Compliance with 6S in the facilities and equipment of the area, quality regulations and GMP's)</li>
<li>Comply/ensure compliance with the General EHS Standards established in the company and specific to the section, legal requirements, Baxter requirements and regulations (ISO and OHSAS)</li>
<li>Participate in department risk assessments, report unsafe situations by completing CIPA, and comply with the EHS training plan, by participating in the EHS risk assessment of your area</li>
<li>Participate in the daily TIER calibration/validation meetings and in the KAIZEN program, contributing ideas for improvement</li>
<li>Collaborate in carrying out calibration tasks that are required, provided that they are trained as a technician in the management of the calibration management system MAXIMUM</li>
<li>Willingness to be trained as an expert in the Maximo program, to act as a backup for the calibration technician if necessary</li>
<li>Comply with data integrity regulations</li>
</ul>
Qualifications and Experience
<ul>
<li>University degree in a technical area (Engineering, chemistry, pharmacy, technical engineering, etc.) or equivalent in experience</li>
<li>Minimum of 1 year of experience in production and/or maintenance and/or quality in the pharmaceutical industry, preferably in the area of validations</li>
<li>Advanced level of English. Spanish is highly valued</li>
<li>Solid understanding of the operation of all the processes of the plant, especially the operation of the autoclaves</li>
<li>Knowledge of GMPs and corporate regulations applicable to the position, especially in relation to the area of validation of measuring instruments, in relation to pharmaceutical products and medical devices</li>
<li>Good command of ISO regulations and applicable legislation and regulations and guidelines related to data integrity</li>
<li>Strong teamwork and communication skills, high capacity for organization and multitasking</li>
<li>Critical thinking, ability to solve technical problems</li>
<li>High technical writing capacity for carrying out procedures, protocols, and reports</li>
<li>Advanced knowledge of Office automation and preferably management of statistical packages (e.g., Minitab or similar)</li>
<li>Knowledge and management of the MAXIMO 7 program, calibration module (Desirable)</li>
</ul>


The Validation Technician monitors the validation plan and oversees the validation management computer system (eVMP), from the assignment of codes to their final file. They are also responsible for autoclave and for creating all types of validation documents.

Essential Duties and Responsibilities


 - Monitoring of the Validation Master Plan and overseeing the validation management computer system (eVMP) and validation documents, from the assignment of codes to their final file

 - Collaborate with the owners of the systems, advising them on the tasks to be carried out to ensure the maintenance of their validation status

 - Carry out all kinds of validation documents and follow up on the execution of the validation tests

 - Prepare protocols and reports for autoclave validations

 - Collaborate in improvement projects and new facilities, collaborating with the staff of other departments for their validation

 - Write and review procedures applicable to the validation area (Compliance with 6S in the facilities and equipment of the area, quality regulations and GMP's)

 - Comply/ensure compliance with the General EHS Standards established in the company and specific to the section, legal requirements, Baxter requirements and regulations (ISO and OHSAS)

 - Participate in department risk assessments, report unsafe situations by completing CIPA, and comply with the EHS training plan, by participating in the EHS risk assessment of your area

 - Participate in the daily TIER calibration/validation meetings and in the KAIZEN program, contributing ideas for improvement

 - Collaborate in carrying out calibration tasks that are required, provided that they are trained as a technician in the management of the calibration management system MAXIMUM

 - Willingness to be trained as an expert in the Maximo program, to act as a backup for the calibration technician if necessary

 - Comply with data integrity regulations


Qualifications and Experience


 - University degree in a technical area (Engineering, chemistry, pharmacy, technical engineering, etc.) or equivalent in experience

 - Minimum of 1 year of experience in production and/or maintenance and/or quality in the pharmaceutical industry, preferably in the area of validations

 - Advanced level of English. Spanish is highly valued

 - Solid understanding of the operation of all the processes of the plant, especially the operation of the autoclaves

 - Knowledge of GMPs and corporate regulations applicable to the position, especially in relation to the area of validation of measuring instruments, in relation to pharmaceutical products and medical devices

 - Good command of ISO regulations and applicable legislation and regulations and guidelines related to data integrity

 - Strong teamwork and communication skills, high capacity for organization and multitasking

 - Critical thinking, ability to solve technical problems

 - High technical writing capacity for carrying out procedures, protocols, and reports

 - Advanced knowledge of Office automation and preferably management of statistical packages (e.g., Minitab or similar)

 - Knowledge and management of the MAXIMO 7 program, calibration module (Desirable)


Validation Technician

The Process Improvement Senior Engineer is responsible for supporting manufacturing in the following duties &amp; responsibilities.
Essential Duties and Responsibilities
&bull; Responsible for managing process changes, process improvement projects, investigations, failure mode and effect analysis, annual report data gathering, instrument/equipment classification, and other quality/safety system requirements in the assigned processes.
&bull; Coordinates the revision/approval of relevant MBR's, SOP's, PCD's as well of other manufacturing related documentation.
&bull; Coordinates activities with Maintenance, Production, Engineering, Safety and Quality departments to support the manufacturing process and have the ability to effectively operator within cross-functional teams.
Coordinates the design and implementation of process improvement projects for the assigned area and prepares relevant documentation changes, including the ones associated to validation.
Provides training to production operators in the utilization of process equipment and the correct ways of performing the required tasks to assure process consistency and expected performance.
Support the operations with area Manager/Supervisor to assure are carried out in a manner that assures product consistency, quality and adequate performance.
Responsible for the documentation coordination related to quality/safety to supporting any investigation and/or troubleshooting in the assigned process areas.
Apply statistical and engineering techniques to solve problems within a project and one-time activities with the necessary guidance.
Adherence to plant safety, environmental and GMP regulations. Hence, candidate must have the ability and/or experience of regulated industry
Qualifications
Bachelor's Degree in Engineering or Relevant technical discipline, preferably a degree in Chemistry/Biology/Pharmaceutics with a broad background in solutions/drug development or applied engineering and the utilization of analytical instrumentation in test methods and process engineering.
Good knowledge of:
&bull; Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service.
&bull; Design Control documentation and process.
&bull; Statistical Analysis and/or Lean/Six Sigma tools.
&bull; International/regional/national regulations and standard


The Process Improvement Senior Engineer is responsible for supporting manufacturing in the following duties &amp; responsibilities.

Essential Duties and Responsibilities

• Responsible for managing process changes, process improvement projects, investigations, failure mode and effect analysis, annual report data gathering, instrument/equipment classification, and other quality/safety system requirements in the assigned processes.

• Coordinates the revision/approval of relevant MBR's, SOP's, PCD's as well of other manufacturing related documentation.

• Coordinates activities with Maintenance, Production, Engineering, Safety and Quality departments to support the manufacturing process and have the ability to effectively operator within cross-functional teams.

Coordinates the design and implementation of process improvement projects for the assigned area and prepares relevant documentation changes, including the ones associated to validation.

Provides training to production operators in the utilization of process equipment and the correct ways of performing the required tasks to assure process consistency and expected performance.

Support the operations with area Manager/Supervisor to assure are carried out in a manner that assures product consistency, quality and adequate performance.

Responsible for the documentation coordination related to quality/safety to supporting any investigation and/or troubleshooting in the assigned process areas.

Apply statistical and engineering techniques to solve problems within a project and one-time activities with the necessary guidance.

Adherence to plant safety, environmental and GMP regulations. Hence, candidate must have the ability and/or experience of regulated industry

Qualifications

Bachelor's Degree in Engineering or Relevant technical discipline, preferably a degree in Chemistry/Biology/Pharmaceutics with a broad background in solutions/drug development or applied engineering and the utilization of analytical instrumentation in test methods and process engineering.

Good knowledge of:

• Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service.

• Design Control documentation and process.

• Statistical Analysis and/or Lean/Six Sigma tools.

• International/regional/national regulations and standard

Sr. Engineer, Manufacturing Engineering

What you'll do
<ul>
<li>Effectively manage logistical operations within the R&amp;D function to support the Malta R&amp;D group testing requirements.&nbsp; This should be in conformance with the applicable requirements.&nbsp;</li>
<li>Manage samples related to R&amp;D testing activities from sample reception to sample discard:&nbsp; carry boxes or pallets to the designated location (with forklift when needed) and keep the traceability of these items.</li>
<li>Manage samples, climatic chambers and areas dedicated to real time and accelerated ageing processes.</li>
<li>Ensure that work area is well maintained also&nbsp;in accordance to EHS regulations related to area of responsibility.&nbsp;</li>
<li>Support in the shipment of samples to other Baxter facilities or to external companies (e.g. for sterilization).</li>
<li>Carry out most of the activities in the warehouse area.</li>
</ul>
What you'll bring
<ul>
<li>O&rsquo; Level Standard of education</li>
<li>ECDL Certification or proficient in using MS Office and Outlook</li>
<li>Fluent in English language: both written and spoken.</li>
<li>Previous working experience in a warehouse environment and lifter user certification are preferred</li>
</ul>


What you'll do


 - Effectively manage logistical operations within the R&amp;D function to support the Malta R&amp;D group testing requirements.
 This should be in conformance with the applicable requirements.


 - Manage samples related to R&amp;D testing activities from sample reception to sample discard:
 carry boxes or pallets to the designated location (with forklift when needed) and keep the traceability of these items.

 - Manage samples, climatic chambers and areas dedicated to real time and accelerated ageing processes.

 - Ensure that work area is well maintained also
in accordance to EHS regulations related to area of responsibility.


 - Support in the shipment of samples to other Baxter facilities or to external companies (e.g. for sterilization).

 - Carry out most of the activities in the warehouse area.


What you'll bring


 - O’ Level Standard of education

 - ECDL Certification or proficient in using MS Office and Outlook

 - Fluent in English language: both written and spoken.

 - Previous working experience in a warehouse environment and lifter user certification are preferred


R&D Samples Coordinator

The Project Designer role will help Baxter in identifying and ensuring that the right information is delivered to our patients all over the globe. This is obtained by helping us create Baxter Labels at excellent quality.


The Project Designer role will help Baxter in identifying and ensuring that the right information is delivered to our patients all over the globe. This is obtained by helping us create Baxter Labels at excellent quality.

Responsibilites


 - The Project Designer officer will ensure that all labels are updated according to the Regulatory Affairs requirements for each and every country Baxter supports.

 - Design control and risk management activities applied to the labelling of medical packages.

 - Ensure that design control and risk management are performed in line with Baxter applicable procedures.

 - Responsible for executing day-to-day activities to support Global Labeling Operations.

 - Understand and leverage Baxter quality practices within your area of responsibility. The Job holder will be required to: Artwork Design (Primary Function)

 - Ensure that Design Artworks have been updated according to the mark up provided.

 - Communicate with stakeholders in order produce update the artworks with the right requirements

 - Work with labelling operations to finalize artwork and proceed with for submission for approval.

 - Expert in GDP, ability to maintain clear traceability with multiple revisions.

 - Design from concept and create/execute designs, layouts and illustrations and publish artwork.

 - Proficient in computer graphics processes and technologies.

 - Proficient knowledge of Adobe software’s like “Photoshop”, “Indesign” &amp; “Illustrator”.

 - Ensure all typesetting of packaging components (including the text, graphics, chemical structures, bar codes etc…) are as per guidelines and standard.

 - Carry out quality control of artwork to ensure high quality and compliant artwork is submitted.

 - Instrumental in preparation of style guides for products (colors, fonts, usage of graphic elements, understanding the layout etc.).

 - Ability to support and drive business targets associated with the labeling operations team (cycle time, accuracy, compliance).

 - Ability to support Global facilities/entities. - Ensure that documentation is in line with FDA Regulations. Artwork Control (Supporting Function)

 - Carry out quality control of artwork to ensure high quality and compliant artwork is submitted.

 - Ensure that Design Artworks have been updated according to the mark up provided.

 - Ensure all typesetting of packaging components (including the text, graphics, chemical structures, bar codes etc…) are as per guidelines and standard.

 - Be proficient in using the software “Global Vision” in order ensure that artworks are updated correctly.

 - Proper Storage and archiving of documents as per local procedure.

 - Document Control (Supporting Function)

 - Trained in GDP, ability to maintain clear traceability with multiple revisions &amp; multiple sign offs.

 - Work with labelling operations to finalize markups.

 - Ensure that documentation is in line with FDA Regulations.

 - Carry uploads of official documents for approval in Baxter Systems for document release.

 - Ensure that all packages are approved as per procedure and filed accordingly. General Duties and Responsibilities

 - Ability to support and drive business targets associated with the labeling operations team (cycle time, accuracy, compliance).

 - Ability to support Global facilities/entities.

 - Ensure to maintain a 6S working environment in the working area.

 - When required, the incumbent shall provide support to the coordinator on project improvements

 - The incumbent is also responsible to ensure that all procedures related to his/her responsibilities are in line with corporate requirements and that any corrective actions triggered by Corporate/Internal/Other audits are always implemented within the established time frames.

 - The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all activities within his role will support EHS targets and will not jeopardize the health and safety of employees and environment.

 - The incumbent must also ensure that all documentation and practices related to her role are in compliance with good laboratory and documentation practices.                  


Qualifications


 - Exceptional organizational skills and ability to support business targets.

 - Experience in using IT Process Oriented Systems

 - Experience in using Adobe software’s like “Photoshop”, “Indesign” &amp; “Illustrator”.

 - Experience of performing design control and document proof reading in accordance to ISO standards.

 - Experienced in using “Docuproof” or similar software’s.

 - Be meticulous and attentive to detail.

 - Experience in quality control would be considered an asset.

 - Good interpersonal and communication skills.

 - Fluent in English (both written and verbal); Fluency in any other language is considered as an asset.   

 - Qualifications:

 - Advanced Diploma or Degree in Art &amp; Design; Graphical Design; ICT; IT; or in an equivalent topic - Or 3 to 5 years work experience working in a similar role.   

 - Completed artwork design certification program at a technical school or satisfactory completion of proficiency examination.   


Labeling Graphic Designer I

You will perform other duties as assigned.
<ul>
<li>Ensure that IT systems (GME / Shipping) are stable and in compliance with Baxter standards</li>
<li>&nbsp;Support and provide technical expertise to end users across the manufacturing and office environment when required</li>
<li>Participate when expected in IT related audits and contribute in preparation and remediation activities Analyze, propose, and lead solutions in line with Baxter standards and procedures</li>
<li>Comply with the process environment conditions and current regulations (cGMP, ERES, EHS, divisional procedures and manuals) Supporting the procurement of IT equipment for employees, using the appropriate procurement channels. e.g handheld &amp; Truck mounted scanning devices</li>
<li>Participate &amp; lead in local and global corporate IT initiatives/projects and business processes to improve the day-to-day operation of the plants</li>
</ul>
Qualifications
<ul>
<li>Strong technical skills, including experience with various operating systems, databases, and programming languages (e.g SQL, SAP, JDE, Oracle )</li>
<li>Effective communication and interpersonal skills, with the ability to work effectively with a variety of stakeholders</li>
<li>Excellent problem-solving and analytical skills</li>
<li>Advanced knowledge about hardware and software configuration</li>
<li>Ability to prioritize tasks and create their work schedules with minimal supervision</li>
<li>Excellent troubleshooting, creative and technical problem-solving skills</li>
</ul>
Education and/or Experience
<ul>
<li>Strong expertise in SQL, including experience with SQL Server, MySQL, or Oracle</li>
<li>Bachelor's degree in Computer Science, Information Technology, or a related field</li>
<li>Use of initiative and take accountability for their work</li>
<li>Good communication skills</li>
</ul>


You will perform other duties as assigned.


 - Ensure that IT systems (GME / Shipping) are stable and in compliance with Baxter standards

 - 
Support and provide technical expertise to end users across the manufacturing and office environment when required

 - Participate when expected in IT related audits and contribute in preparation and remediation activities
Analyze, propose, and lead solutions in line with Baxter standards and procedures

 - Comply with the process environment conditions and current regulations (cGMP, ERES, EHS, divisional procedures and manuals)
Supporting the procurement of IT equipment for employees, using the appropriate procurement channels. e.g handheld &amp; Truck mounted scanning devices

 - Participate &amp; lead in local and global corporate IT initiatives/projects and business processes to improve the day-to-day operation of the plants


Qualifications


 - Strong technical skills, including experience with various operating systems, databases, and programming languages (e.g SQL, SAP, JDE, Oracle )

 - Effective communication and interpersonal skills, with the ability to work effectively with a variety of stakeholders

 - Excellent problem-solving and analytical skills

 - Advanced knowledge about hardware and software configuration

 - Ability to prioritize tasks and create their work schedules with minimal supervision

 - Excellent troubleshooting, creative and technical problem-solving skills


Education and/or Experience


 - Strong expertise in SQL, including experience with SQL Server, MySQL, or Oracle

 - Bachelor's degree in Computer Science, Information Technology, or a related field

 - Use of initiative and take accountability for their work

 - Good communication skills


IT Analyst

Responsibilities
The Specialist Calibration is part of the Quality Assurance Production Control Team and responsible for the test equipment management. Very good knowledge in the field of technology and calibration are essential.
<ul>
<li>
Planning, evaluation and documentation, approval of calibrations of different test characteristics at the site
</li>
<li>
Consideration of regulations regarding reference standards and application of GMP/GDP when performing calibrations&nbsp;
</li>
<li>
Collaboration in the non-conformance reports (NCR) and corrective and preventive action (CAPA) processing
</li>
<li>
Review and approval of local QM documents (calibration records)
</li>
<li>
Test equipment management: monitoring, control (planning), testing, maintenance (updating) of all test equipment at the site - software-base
</li>
</ul>
Qualifications
<ul>
<li>
Completed university education or completed vocational or professional education with at least 3 years of professional experience in the field of medical devices or quality management&nbsp;
</li>
<li>
Secure knowledge of German (fluent) and English&nbsp;
</li>
<li>
Experience with databases - preferably "TrackWise"
</li>
<li>
Confident use of MS Office&nbsp;
</li>
<li>
Ability to work in a team&nbsp;
</li>
<li>
Solution-oriented way of working&nbsp;
</li>
</ul>


Responsibilities

The Specialist Calibration is part of the Quality Assurance Production Control Team and responsible for the test equipment management. Very good knowledge in the field of technology and calibration are essential.


 - 

Planning, evaluation and documentation, approval of calibrations of different test characteristics at the site


 - 

Consideration of regulations regarding reference standards and application of GMP/GDP when performing calibrations



 - 

Collaboration in the non-conformance reports (NCR) and corrective and preventive action (CAPA) processing


 - 

Review and approval of local QM documents (calibration records)


 - 

Test equipment management: monitoring, control (planning), testing, maintenance (updating) of all test equipment at the site - software-base



Qualifications


 - 

Completed university education or completed vocational or professional education with at least 3 years of professional experience in the field of medical devices or quality management



 - 

Secure knowledge of German (fluent) and English



 - 

Experience with databases - preferably "TrackWise"


 - 

Confident use of MS Office



 - 

Ability to work in a team



 - 

Solution-oriented way of working




Specialist Calibration

We are looking for a talented Import/Export Coordinator to support our Supply Chain, Planning and Fulfillment team in Malta and Tunisia.
The Import/Export Coordinator have the responsibility to arrange and coordinate inbound product shipments into and out of the UK, ensuring conformance to internal (eg Baxter) and external (eg HMRC) regulations; process the export of all Baxter finished goods and raw materials out of the UK and all transactions in accordance with international trade regulations and legislation.
Essential duties and responsibilities:
<ul>
<li>
Co-ordinate the export order cycle, by checking inventory availability, processing orders, building loads, preparing documentation, and handling transportation.
</li>
<li>
Select appropriate transport methods to ensure safe and timely delivery of products to receiving site
</li>
<li>
Provide 24/7 call-out standby cover, for out-of-hours shipments.
</li>
<li>
Monitor the agreed freight rates by carrier and maintain / update the Penske system to ensure all loads keep moving from Thetford.
</li>
<li>
Plan, in conjunction with Manufacturing key personnel, the receipt of inbound raw materials and WIP into Thetford, ensuring conformance to Baxter and HRMC regulations. Also plans the receipt of finished goods into the NDC, with similar conformance
</li>
<li>
Analyse current and proposed HMRC regulations, so that Baxter conformances reflects current requirements and is legal.
</li>
<li>
Work with the UK Freight Clearing Agents and Forwarders to facilitate smooth flow of inbound product from UK point of entry to Thetford Plant and NDC.
</li>
<li>
Approve invoices for payment, as appropriate
</li>
<li>
Provide manufacturing key personnel with all data relevant to inbound product, e.g. in-transit temperature monitoring
</li>
<li>
Validate Thetford Compounding transport invoices, matching invoice detail to physical dispatches
</li>
</ul>
Fundamental requirements:
<ul>
<li>
Knowledge of UK and European VAT
</li>
<li>
Full understanding of inbound product clearing processes
</li>
<li>
Comprehensive understanding of Inventory related systems and processes
</li>
<li>
Good numeracy and analytical skills
</li>
<li>
Understanding of international import / export documentation
</li>
<li>
Understanding principles of Letters of Credit
</li>
<li>
Export documentation/HM Customs &amp; Excise rules/Knowledge of Baxter products
</li>
<li>
Fluency in English
</li>
</ul>


We are looking for a talented Import/Export Coordinator to support our Supply Chain, Planning and Fulfillment team in Malta and Tunisia.

The Import/Export Coordinator have the responsibility to arrange and coordinate inbound product shipments into and out of the UK, ensuring conformance to internal (eg Baxter) and external (eg HMRC) regulations; process the export of all Baxter finished goods and raw materials out of the UK and all transactions in accordance with international trade regulations and legislation.

Essential duties and responsibilities:


 - 

Co-ordinate the export order cycle, by checking inventory availability, processing orders, building loads, preparing documentation, and handling transportation.


 - 

Select appropriate transport methods to ensure safe and timely delivery of products to receiving site


 - 

Provide 24/7 call-out standby cover, for out-of-hours shipments.


 - 

Monitor the agreed freight rates by carrier and maintain / update the Penske system to ensure all loads keep moving from Thetford.


 - 

Plan, in conjunction with Manufacturing key personnel, the receipt of inbound raw materials and WIP into Thetford, ensuring conformance to Baxter and HRMC regulations. Also plans the receipt of finished goods into the NDC, with similar conformance


 - 

Analyse current and proposed HMRC regulations, so that Baxter conformances reflects current requirements and is legal.


 - 

Work with the UK Freight Clearing Agents and Forwarders to facilitate smooth flow of inbound product from UK point of entry to Thetford Plant and NDC.


 - 

Approve invoices for payment, as appropriate


 - 

Provide manufacturing key personnel with all data relevant to inbound product, e.g. in-transit temperature monitoring


 - 

Validate Thetford Compounding transport invoices, matching invoice detail to physical dispatches



Fundamental requirements:


 - 

Knowledge of UK and European VAT


 - 

Full understanding of inbound product clearing processes


 - 

Comprehensive understanding of Inventory related systems and processes


 - 

Good numeracy and analytical skills


 - 

Understanding of international import / export documentation


 - 

Understanding principles of Letters of Credit


 - 

Export documentation/HM Customs &amp; Excise rules/Knowledge of Baxter products


 - 

Fluency in English



Import / Export Coordinator

We are seeking a&nbsp;Documentation Specialist&nbsp;to join us. As a Documentation Specialist you will work closely with our Training and Compliance, Validation, Engineering and Manufacturing teams.
What you will be doing
<ul>
<li>Collaborate with departments and process documentation on &nbsp;Baxter Documentation system Team centre (TCU)</li>
<li>Perform issuance of Documentation post approval on &nbsp;Baxter Documentation system TCU</li>
<li>Perform Obsoletion of documentation as required</li>
<li>Coordinate periodic review of documents</li>
<li>Complete role in compliance with current Global &nbsp;issued and effective documents and coordinate global document implementation on site</li>
<li>Issue/ coordinate&nbsp;&nbsp;documentation-related&nbsp;training to site</li>
<li>Coordinate archiving of document</li>
<li>Identify and Implement improvements to documentation and associated &nbsp;processes</li>
<li>Project support activities and provide guidance to others on documentation activities/ processes</li>
<li>Participate in Internal/ External Audits as required</li>
<li>Perform other Documentation Activities as required by the team</li>
<li>Compliance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)</li>
<li>Compliance to Environmental Health &amp; Safety (EHS) requirements</li>
<li>Any other Documentation Specialist activities as the need arises</li>
</ul>
What you will have
<ul>
<li>Fluent In English</li>
<li>The ability to communicate and work well with team members, in a conscientious and inclusive way</li>
</ul>
<ul>
<li>Ideally experience in a Quality/regulated environment</li>
<li>Excellent attention to detail</li>
<li>The ability for critical thinking and problem solving</li>
<li>Good organisational, coordination, and communication skills</li>
<li>Good working knowledge of Microsoft Applications, Word/ Excel, PowerPoint,</li>
<li>Good working knowledge of Team&nbsp;centre&nbsp;(TCU), Trackwise Change control, would be an advantage</li>
<li>Highly motivated self-starter and team worker</li>
<li>Effectively handle high-volume and prioritization of tasks</li>
<li>Flexible with working hours to support needs of business where relevant</li>
</ul>


We are seeking a
Documentation Specialist
to join us. As a Documentation Specialist you will work closely with our Training and Compliance, Validation, Engineering and Manufacturing teams.

What you will be doing


 - Collaborate with departments and process documentation on 
Baxter Documentation system Team centre (TCU)

 - Perform issuance of Documentation post approval on 
Baxter Documentation system TCU

 - Perform Obsoletion of documentation as required

 - Coordinate periodic review of documents

 - Complete role in compliance with current Global 
issued and effective documents and coordinate global document implementation on site

 - Issue/ coordinate

documentation-related
training to site

 - Coordinate archiving of document

 - Identify and Implement improvements to documentation and associated 
processes

 - Project support activities and provide guidance to others on documentation activities/ processes

 - Participate in Internal/ External Audits as required

 - Perform other Documentation Activities as required by the team

 - Compliance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

 - Compliance to Environmental Health &amp; Safety (EHS) requirements

 - Any other Documentation Specialist activities as the need arises


What you will have


 - Fluent In English

 - The ability to communicate and work well with team members, in a conscientious and inclusive way



 - Ideally experience in a Quality/regulated environment

 - Excellent attention to detail

 - The ability for critical thinking and problem solving

 - Good organisational, coordination, and communication skills

 - Good working knowledge of Microsoft Applications, Word/ Excel, PowerPoint,

 - Good working knowledge of Team
centre
(TCU), Trackwise Change control, would be an advantage

 - Highly motivated self-starter and team worker

 - Effectively handle high-volume and prioritization of tasks

 - Flexible with working hours to support needs of business where relevant


Documentation Specialist

The Logistics Administrator reports to the Logistics Manager.
They are responsible for monitoring production, managing the transportation of the product and documentation related to national, export and import shipments in accordance with current procedures.
The Logistics Administrator is part of the supply chain area and must be customer oriented to ensure compliance with the agreed contractual conditions as well as to satisfy their needs and expectations. Communication with Customer Service or direct customers must be correct, precise, effective and without delays in order to achieve the highest level of customer satisfaction.
Essential Duties and Responsibilities
<ul>
<li>Understand and manage the systems while complying with the procedures of the plant that affect the functions of their position as well as the general EHS standards established in the company, the standards of the GMP Quality system and the data integrity regulations</li>
<li>Achieve and maintain the indicators set for your position and work actively to achieve the objectives of the department</li>
<li>Reception of customer orders and distribution within the plant</li>
<li>Process orders in the computer system</li>
<li>Monitor the production and quality status of the finished product</li>
<li>Preparation of outputs of finished product and other shipments from the plant in conditions that guarantee their integrity and optimal use of resources in accordance with established procedures</li>
<li>Cargo management and transport contracting</li>
<li>Track shipments, meet delivery dates and communicate delivery dates to customers</li>
<li>Coordinate customer returns</li>
<li>Keep the warehouse informed about product shipments and customer returns</li>
<li>Preparation of documentation in import and export operations: packing list, invoice, manufacturing and/or export authorizations before the AEM customs, notification of exports and imports, certificates of origin</li>
<li>Carry out the necessary administrative procedures to guarantee the transit of merchandise between different countries</li>
<li>Management of transport claims</li>
</ul>
Qualifications and Experience
<ul>
<li>University degree (technical, scientific, or business administration and management) preferred</li>
<li>Experience in Logistics and Transport as well as Foreign Trade will be valued</li>
<li>Minimum of one year of experience in a similar position</li>
<li>Advanced level of English. Spanish will be highly valued</li>
<li>Resourceful IT user (Microsoft programs)</li>
<li>Strong communication and teamwork skills</li>
</ul>


The Logistics Administrator reports to the Logistics Manager.

They are responsible for monitoring production, managing the transportation of the product and documentation related to national, export and import shipments in accordance with current procedures.

The Logistics Administrator is part of the supply chain area and must be customer oriented to ensure compliance with the agreed contractual conditions as well as to satisfy their needs and expectations. Communication with Customer Service or direct customers must be correct, precise, effective and without delays in order to achieve the highest level of customer satisfaction.

Essential Duties and Responsibilities


 - Understand and manage the systems while complying with the procedures of the plant that affect the functions of their position as well as the general EHS standards established in the company, the standards of the GMP Quality system and the data integrity regulations

 - Achieve and maintain the indicators set for your position and work actively to achieve the objectives of the department

 - Reception of customer orders and distribution within the plant

 - Process orders in the computer system

 - Monitor the production and quality status of the finished product

 - Preparation of outputs of finished product and other shipments from the plant in conditions that guarantee their integrity and optimal use of resources in accordance with established procedures

 - Cargo management and transport contracting

 - Track shipments, meet delivery dates and communicate delivery dates to customers

 - Coordinate customer returns

 - Keep the warehouse informed about product shipments and customer returns

 - Preparation of documentation in import and export operations: packing list, invoice, manufacturing and/or export authorizations before the AEM customs, notification of exports and imports, certificates of origin

 - Carry out the necessary administrative procedures to guarantee the transit of merchandise between different countries

 - Management of transport claims


Qualifications and Experience


 - University degree (technical, scientific, or business administration and management) preferred

 - Experience in Logistics and Transport as well as Foreign Trade will be valued

 - Minimum of one year of experience in a similar position

 - Advanced level of English. Spanish will be highly valued

 - Resourceful IT user (Microsoft programs)

 - Strong communication and teamwork skills


Logistics & Expeditions Clerk

Covering this role as Quality System Technician you'll report hierarchically and functionally to the Quality System Supervisor.
You will collaborate with all the&nbsp;Quality&nbsp;System&nbsp;team&nbsp;for the management of Documentation, Training, Change Control and Supplier.
You'll support the team to Maintain and Ensures Quality System is effectively implemented in Italian sites in accordance with internal and global procedures.
What you&rsquo;ll do
​Change&nbsp;Control: 15 %
<ul>
<li>Technical support on TW8 system (e.g&nbsp;extension, status change, amendments)</li>
<li>Initiator, analysis assignment and planning review</li>
<li>Due date and target monitoring, follow up with owner</li>
<li>General review of the record to check if requirement have been met using dedicated check list</li>
<li>Participate&nbsp;to global call</li>
</ul>
Documentation: 40 %
<ul>
<li>Upload documents on Baxter system (e.gTcU, BOM, share point, cloud)</li>
<li>Obsolete&nbsp;documents</li>
<li>Review documentation to check if requirements have been met using dedicated check list</li>
<li>Create or update&nbsp;specificdocuments</li>
</ul>
Training: 25 %
<ul>
<li>Upload training record on Baxter system</li>
<li>Follow up with Global team to on-site training issue</li>
</ul>
Supplier: 20 %
<ul>
<li>Support site supplier SME to manage records in the system updated on time</li>
<li>Due date and target monitoring, follow up with owner</li>
</ul>
Whatyou&rsquo;llbring
<ul>
<li>
High school diploma or&nbsp;Bachelor Degree&nbsp;or relevant work experience
</li>
<li>
Good written and verbal communication skills and the ability for autonomy and teamwork
</li>
<li>
Good knowledge of English and in Italian&nbsp;languages (written and spoken)
</li>
<li>
Good interaction skills with diplomacy and tact, showing tenacity and mediation skills
</li>
<li>
Good&nbsp;problem solving&nbsp;skills
</li>
<li>
Good knowledge of Outlook, Excel, Word, PowerPoint, Microsoft Teams tools and IT oriented for company software usage (e.gTrackwise,&nbsp;TcU)
</li>
</ul>


Covering this role as Quality System Technician you'll report hierarchically and functionally to the Quality System Supervisor.

You will collaborate with all the
Quality
System
team
for the management of Documentation, Training, Change Control and Supplier.

You'll support the team to Maintain and Ensures Quality System is effectively implemented in Italian sites in accordance with internal and global procedures.

What you’ll do

​Change
Control: 15 %


 - Technical support on TW8 system (e.g
extension, status change, amendments)

 - Initiator, analysis assignment and planning review

 - Due date and target monitoring, follow up with owner

 - General review of the record to check if requirement have been met using dedicated check list

 - Participate
to global call


Documentation: 40 %


 - Upload documents on Baxter system (e.gTcU, BOM, share point, cloud)

 - Obsolete
documents

 - Review documentation to check if requirements have been met using dedicated check list

 - Create or update
specificdocuments


Training: 25 %


 - Upload training record on Baxter system

 - Follow up with Global team to on-site training issue


Supplier: 20 %


 - Support site supplier SME to manage records in the system updated on time

 - Due date and target monitoring, follow up with owner


Whatyou’llbring


 - 

High school diploma or
Bachelor Degree
or relevant work experience


 - 

Good written and verbal communication skills and the ability for autonomy and teamwork


 - 

Good knowledge of English and in Italian
languages (written and spoken)


 - 

Good interaction skills with diplomacy and tact, showing tenacity and mediation skills


 - 

Good
problem solving
skills


 - 

Good knowledge of Outlook, Excel, Word, PowerPoint, Microsoft Teams tools and IT oriented for company software usage (e.gTrackwise,
TcU)



Quality System Technician

Summary
A great opportunity&nbsp;has recently arisen for a Quality&nbsp;Management System Tech&nbsp;to join&nbsp;our Quality Team in Malta.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their&nbsp;expertise&nbsp;and hold each other accountable. We feel empowered to speak up when&nbsp;there's&nbsp;a new insight or opportunity to improve something. This open dialogue builds trust within the team and helps create a better product for our customers.
What&nbsp;you'll&nbsp;be doing
<ul>
<li>Act asDocument Author,&nbsp;Electronic System for Documentation Management&nbsp;Local administrator</li>
<li>Act as Local Administrator&nbsp;of the Electronic System for the management of printed version of paper&nbsp;document</li>
<li>Guarantee&nbsp;the correct application of requirements for document control (System of Record) and lifecycle at the Site</li>
</ul>
<ul>
<li>Acts as local contact and site coach for&nbsp;Documentation Electronic Systems&nbsp;issues and supports local deployment of system enhancements</li>
<li>Supports the local internal training process of&nbsp;QMS&nbsp;Documents</li>
</ul>
What&nbsp;you'll&nbsp;bring
<ul>
<li>
Scientific&nbsp;Bachelor's or Master's&nbsp;degree&nbsp;is preferred(we can&nbsp;also evaluate&nbsp;candidates with&nbsp;degree in other fields, such as&nbsp;Foreign Language)
</li>
<li>
Experience&nbsp;in&nbsp;QMS Documentation Management and knowledge of relevant quality documents and standards&nbsp;(eg.ISO&nbsp;13485 and 21&nbsp;CFR&nbsp;Part 820)&nbsp;is recommended&nbsp;
</li>
<li>
Very good&nbsp;knowledge of English language, both verbal and in writing;&nbsp;Italian&nbsp;knowledgeis required
</li>
<li>
Attitude to&nbsp;work with a focus on implementation, result driven and ability to&nbsp;accomplish&nbsp;agreed objectives
</li>
<li>
Communication skills and ability to work with different&nbsp;stakeholders (located&nbsp;in the Site and other&nbsp;locations)
</li>
</ul>


Summary

A great opportunity
has recently arisen for a Quality
Management System Tech
to join
our Quality Team in Malta.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their
expertise
and hold each other accountable. We feel empowered to speak up when
there's
a new insight or opportunity to improve something. This open dialogue builds trust within the team and helps create a better product for our customers.

What
you'll
be doing


 - Act asDocument Author,
Electronic System for Documentation Management
Local administrator

 - Act as Local Administrator
of the Electronic System for the management of printed version of paper
document

 - Guarantee
the correct application of requirements for document control (System of Record) and lifecycle at the Site



 - Acts as local contact and site coach for
Documentation Electronic Systems
issues and supports local deployment of system enhancements

 - Supports the local internal training process of
QMS
Documents


What
you'll
bring


 - 

Scientific
Bachelor's or Master's
degree
is preferred(we can
also evaluate
candidates with
degree in other fields, such as
Foreign Language)


 - 

Experience
in
QMS Documentation Management and knowledge of relevant quality documents and standards
(eg.ISO
13485 and 21
CFR
Part 820)
is recommended



 - 

Very good
knowledge of English language, both verbal and in writing;
Italian
knowledgeis required


 - 

Attitude to
work with a focus on implementation, result driven and ability to
accomplish
agreed objectives


 - 

Communication skills and ability to work with different
stakeholders (located
in the Site and other
locations)



Quality Management System Technician

The Operational Buyer is responsible for the raw material planning and purchasing activities needed to support the production.
Responsibilities
<ul>
<li>
Continuous improvement of the procurement processes together with procurement
</li>
<li>
Accountable for the coordination of raw material with procurement team
</li>
<li>
Establish and maintain effective communication with the suppliers about delivery time order volumes, orders, order confirmations and changes
</li>
<li>
Review and evaluate RapidResponse order proposals or current production plans, coordinate and fine tune as necessary, including directly with supplier and production planning and productions.
</li>
<li>
Preparation of short, mid and longterm plans for supplier and procurement also for budget process
</li>
<li>
Responsible for archiving procurement documents
</li>
<li>
Participates in the weekly planning meeting, coordinates the needs of all raw materials for the production in Hechingen/Germany and Meyzieu/France.
</li>
<li>
Provides production with the goods, necessary to fulfill the production plan
</li>
<li>
Responsible for the procurement of goods, services and investments according to the specified quality standards
</li>
<li>
Actively participates in the working group for design change, label change, revision change
</li>
<li>
Direct contact with warehouse if inbounds are not matching the delivery notes or purchasing orders
</li>
<li>
Manage Label and Revision-Change
</li>
<li>
Communicate stock level of all raw material with Controlling &ndash; check targets
</li>
<li>
Control and communicate obsolescence risk of raw-materia.
</li>
<li>
Communicate and coordinate the scrapping of obsolete or phased out materials with controller, production and warehouse
</li>
</ul>
Qualifications
<ul>
<li>
Completed commercial vocational training
</li>
<li>
Knowledge regarding regulatory requirements
</li>
<li>
Mastery of operational procurement processes
</li>
<li>
Knowledge of business contexts
</li>
<li>
Mastery of modern procurement methods
</li>
<li>
Knowledge in Microsoft Tools (Office, Excel), Pega Target II, JD Edwards (GME)
</li>
<li>
Language skills: fluent German, min. advanced knowledge of English
</li>
</ul>


The Operational Buyer is responsible for the raw material planning and purchasing activities needed to support the production.

Responsibilities


 - 

Continuous improvement of the procurement processes together with procurement


 - 

Accountable for the coordination of raw material with procurement team


 - 

Establish and maintain effective communication with the suppliers about delivery time order volumes, orders, order confirmations and changes


 - 

Review and evaluate RapidResponse order proposals or current production plans, coordinate and fine tune as necessary, including directly with supplier and production planning and productions.


 - 

Preparation of short, mid and longterm plans for supplier and procurement also for budget process


 - 

Responsible for archiving procurement documents


 - 

Participates in the weekly planning meeting, coordinates the needs of all raw materials for the production in Hechingen/Germany and Meyzieu/France.


 - 

Provides production with the goods, necessary to fulfill the production plan


 - 

Responsible for the procurement of goods, services and investments according to the specified quality standards


 - 

Actively participates in the working group for design change, label change, revision change


 - 

Direct contact with warehouse if inbounds are not matching the delivery notes or purchasing orders


 - 

Manage Label and Revision-Change


 - 

Communicate stock level of all raw material with Controlling – check targets


 - 

Control and communicate obsolescence risk of raw-materia.


 - 

Communicate and coordinate the scrapping of obsolete or phased out materials with controller, production and warehouse



Qualifications


 - 

Completed commercial vocational training


 - 

Knowledge regarding regulatory requirements


 - 

Mastery of operational procurement processes


 - 

Knowledge of business contexts


 - 

Mastery of modern procurement methods


 - 

Knowledge in Microsoft Tools (Office, Excel), Pega Target II, JD Edwards (GME)


 - 

Language skills: fluent German, min. advanced knowledge of English



Operational Buyer

The Planning Clerk reports to the Plant Supply Chain Manager.
They are responsible for the production planning of the plant and for carrying out local and European tasks related to the plant. They coordinate and expedite the flow of work and materials within or between departments of an establishment according to production schedule.
Essential Duties and Responsibilities
<ul>
<li>The most important tasks performed by the planning administrator are:</li>
<li>For Sabi&ntilde;&aacute;nigo production planning:</li>
<li>Reconciliation of the Viaflo inventory at the end of the month and capture of the sales forecasts</li>
<li>Preparation of the daily production program and execution of the</li>
<li>daily batch documentation</li>
<li>Daily review of the situation of finished product codes (back order, low cover)</li>
<li>Management of raw materials, inventory situation and purchasing needs.</li>
<li>Management of batches in hold and in reinspection and release of reinspection documentation</li>
<li>Management of new finished product codes</li>
<li>For San Vittore Production Planning:</li>
<li>Reconciliation of the film inventory at the end of the month and capture of the sales forecasts</li>
<li>Preparation of the monthly production schedule and the weekly schedule for sending film to the plants</li>
<li>Comply / ensure compliance with the General EHS Standards established in the company and specific to the Section. Legal requirements, Baxter requirements, and regulations (ISO and OHSAS)</li>
</ul>
Qualifications and Experience
<ul>
<li>University degree (technical, scientific, or business administration and management). MS Degree in Logistics/Supply Chain would be preferred</li>
<li>Minimum of one year of experience in a management/administration position</li>
<li>Advanced level of English. Spanish will be highly valued</li>
<li>Resourceful IT user (Microsoft programs)</li>
<li>Software knowledge will be highly valued: Enterprise Resource Planning software (ERP) and Production Planning tools (JDE environments)</li>
<li>General principles of inventory management systems</li>
<li>Strong communication and teamwork skills</li>
</ul>


The Planning Clerk reports to the Plant Supply Chain Manager.

They are responsible for the production planning of the plant and for carrying out local and European tasks related to the plant. They coordinate and expedite the flow of work and materials within or between departments of an establishment according to production schedule.

Essential Duties and Responsibilities


 - The most important tasks performed by the planning administrator are:

 - For Sabiñánigo production planning:

 - Reconciliation of the Viaflo inventory at the end of the month and capture of the sales forecasts

 - Preparation of the daily production program and execution of the

 - daily batch documentation

 - Daily review of the situation of finished product codes (back order, low cover)

 - Management of raw materials, inventory situation and purchasing needs.

 - Management of batches in hold and in reinspection and release of reinspection documentation

 - Management of new finished product codes

 - For San Vittore Production Planning:

 - Reconciliation of the film inventory at the end of the month and capture of the sales forecasts

 - Preparation of the monthly production schedule and the weekly schedule for sending film to the plants

 - Comply / ensure compliance with the General EHS Standards established in the company and specific to the Section. Legal requirements, Baxter requirements, and regulations (ISO and OHSAS)


Qualifications and Experience


 - University degree (technical, scientific, or business administration and management). MS Degree in Logistics/Supply Chain would be preferred

 - Minimum of one year of experience in a management/administration position

 - Advanced level of English. Spanish will be highly valued

 - Resourceful IT user (Microsoft programs)

 - Software knowledge will be highly valued: Enterprise Resource Planning software (ERP) and Production Planning tools (JDE environments)

 - General principles of inventory management systems

 - Strong communication and teamwork skills


Planning Clerk (Production)

Responsibilities
The Replenishment Planner is part of the Logistic Team and responsible for:
<ul>
<li>
Close Cooperation with the Network Planner. Check and align outcome from our supply chain planning tool (RapidResponse) with feedback from Customer Support and real Demand
</li>
<li>
Continuous improvement of the supply chain process together with the Network Planner and Customer Support and Baxter warehouses but also KTN-Warehouse
</li>
<li>
Check Demand coming from RapidResponse with existing stock &ndash; book volumes to the different branch plants &ndash; communicate with customer support
</li>
<li>
Check demand with Customer Support and Market Execution (Market Fulfillment), balance with Network Planner and outcome from RapidResponse
</li>
<li>
Review and align transfer orders to demand
</li>
<li>
Review transfer order, exceptions and cancel, decrease or postpone orders if necessary
</li>
<li>
Firm planned transfer orders and send to target closed loop system
</li>
</ul>
Qualifications
<ul>
<li>
Completed commercial vocational training
</li>
<li>
Knowledge regarding regulatory requirements
</li>
<li>
Mastery of operational procurement processes
</li>
<li>
Knowledge of business contexts
</li>
<li>
Mastery of modern procurement methods
</li>
<li>
Knowledge in Microsoft Tools (Office, Excel), RapidResponse and JD Edwards (GME + B4ONE)
</li>
<li>
Language skills: min. advanced knowledge of English
</li>
</ul>


Responsibilities

The Replenishment Planner is part of the Logistic Team and responsible for:


 - 

Close Cooperation with the Network Planner. Check and align outcome from our supply chain planning tool (RapidResponse) with feedback from Customer Support and real Demand


 - 

Continuous improvement of the supply chain process together with the Network Planner and Customer Support and Baxter warehouses but also KTN-Warehouse


 - 

Check Demand coming from RapidResponse with existing stock – book volumes to the different branch plants – communicate with customer support


 - 

Check demand with Customer Support and Market Execution (Market Fulfillment), balance with Network Planner and outcome from RapidResponse


 - 

Review and align transfer orders to demand


 - 

Review transfer order, exceptions and cancel, decrease or postpone orders if necessary


 - 

Firm planned transfer orders and send to target closed loop system



Qualifications


 - 

Completed commercial vocational training


 - 

Knowledge regarding regulatory requirements


 - 

Mastery of operational procurement processes


 - 

Knowledge of business contexts


 - 

Mastery of modern procurement methods


 - 

Knowledge in Microsoft Tools (Office, Excel), RapidResponse and JD Edwards (GME + B4ONE)


 - 

Language skills: min. advanced knowledge of English



Replenishment Planner - Part time

The Labeling Project Leader is responsible for leading multiple projects within a product labeling program from initiation through project closure with limited direction. This person will ensure that labeling changes are produced and implemented at the associated manufacturing plant.&nbsp;The Project Leader facilitates meetings and communicates with stakeholders to ensure the project adheres to the schedule and scope, and delivers to commitments.&nbsp;
Essential Scope of Project Leader:
<ul>
<li>Responsible for owning, managing and monitoring multiple simple to moderate labeling projects from initiation through completion</li>
<li>Develops and writes a project scope summary description and rationale based on the labeling request&rsquo;s scope and requirements</li>
<li>Determine execution strategy in change management system</li>
<li>Develop change plans activities and monitor activity closure</li>
<li>Create and manage schedules to track projects to service level agreements</li>
<li>Interact with global manufacturing plants to implement labeling on product</li>
<li>Collaborate with global stakeholders to drive projects to completion</li>
<li>Facilitate meetings to resolve project conflicts</li>
<li>Monitor and control projects throughout the project lifecycle to mitigate and eliminate risks, resolve issues, schedule delays and resource constraints</li>
<li>The incumbent will perform other duties as assigned</li>
</ul>
Qualifications:
<ul>
<li>Experience in a global environment in pharmaceutical labeling or regulated industries preferred</li>
<li>Customer minded with good interpersonal and communication skills and the ability to interact effectively with all levels of local and international organization</li>
<li>Proficient use of Microsoft Office (Word, PowerPoint, Excel, OneNote, SharePoint)</li>
<li>Experience understanding project schedules, Microsoft Project a plus</li>
<li>Understanding of labeling, translation, change control processes and data management systems helpful</li>
<li>Experience with global cross-functional team meetings</li>
<li>Knowledge of change management systems preferred</li>
</ul>
Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree or equivalent experience</li>
<li>1-2 years of experience in project management or change management</li>
<li>Working experience in a regulated industry</li>
</ul>


The Labeling Project Leader is responsible for leading multiple projects within a product labeling program from initiation through project closure with limited direction. This person will ensure that labeling changes are produced and implemented at the associated manufacturing plant.
The Project Leader facilitates meetings and communicates with stakeholders to ensure the project adheres to the schedule and scope, and delivers to commitments.


Essential Scope of Project Leader:


 - Responsible for owning, managing and monitoring multiple simple to moderate labeling projects from initiation through completion

 - Develops and writes a project scope summary description and rationale based on the labeling request’s scope and requirements

 - Determine execution strategy in change management system

 - Develop change plans activities and monitor activity closure

 - Create and manage schedules to track projects to service level agreements

 - Interact with global manufacturing plants to implement labeling on product

 - Collaborate with global stakeholders to drive projects to completion

 - Facilitate meetings to resolve project conflicts

 - Monitor and control projects throughout the project lifecycle to mitigate and eliminate risks, resolve issues, schedule delays and resource constraints

 - The incumbent will perform other duties as assigned


Qualifications:


 - Experience in a global environment in pharmaceutical labeling or regulated industries preferred

 - Customer minded with good interpersonal and communication skills and the ability to interact effectively with all levels of local and international organization

 - Proficient use of Microsoft Office (Word, PowerPoint, Excel, OneNote, SharePoint)

 - Experience understanding project schedules, Microsoft Project a plus

 - Understanding of labeling, translation, change control processes and data management systems helpful

 - Experience with global cross-functional team meetings

 - Knowledge of change management systems preferred


Education and Experience:


 - Bachelor’s degree or equivalent experience

 - 1-2 years of experience in project management or change management

 - Working experience in a regulated industry


Project Leader - Labelling

We are looking for Training &amp; Quality Coordinator to join our Quality team in Malta and Tunsia.
Reporting to the Quality Systems and Validation Manager ,you will proactively support the development and implementation of the plant training program and support in the reporting of key quality metrics in line with the company strategic plan.
Essential Duties and Responsibilities
Training
<ul>
<li>
Develop and maintain a training matrix for indirect staff.
</li>
<li>
Site contact and super user for BAXU and participate in EMEA/Global Learning Professional network
</li>
<li>
Site BAXU Learning Professional responsible for supporting on site staff to ensure that compliance to SOP&rsquo;s and training KPIs is consistently met
</li>
<li>
Supporting Team Leaders and Mangers to ensure that training records are maintained as per ongoing requirements
</li>
<li>
Training, coaching, and supporting staff and managers for BAXU
</li>
</ul>
Documentation
<ul>
<li>
Managing periodic document review process including tracking and trending completion
</li>
<li>
KPI reporting as relates to quality metrics in Documentation
</li>
<li>
Responsible for digitalization of training related forms.
</li>
</ul>
Fundamental requirement:
<ul>
<li>Excellent attention to details</li>
<li>Experience within the pharmaceutical / medical device industry</li>
<li>Experience in a quality function</li>
<li>Fluency in written and spoken English</li>
</ul>


We are looking for Training &amp; Quality Coordinator to join our Quality team in Malta and Tunsia.

Reporting to the Quality Systems and Validation Manager ,you will proactively support the development and implementation of the plant training program and support in the reporting of key quality metrics in line with the company strategic plan.

Essential Duties and Responsibilities

Training


 - 

Develop and maintain a training matrix for indirect staff.


 - 

Site contact and super user for BAXU and participate in EMEA/Global Learning Professional network


 - 

Site BAXU Learning Professional responsible for supporting on site staff to ensure that compliance to SOP’s and training KPIs is consistently met


 - 

Supporting Team Leaders and Mangers to ensure that training records are maintained as per ongoing requirements


 - 

Training, coaching, and supporting staff and managers for BAXU



Documentation


 - 

Managing periodic document review process including tracking and trending completion


 - 

KPI reporting as relates to quality metrics in Documentation


 - 

Responsible for digitalization of training related forms.



Fundamental requirement:


 - Excellent attention to details

 - Experience within the pharmaceutical / medical device industry

 - Experience in a quality function

 - Fluency in written and spoken English


Training & Quality Coordinator

We are looking for Quality System Coordinator to support our Quality team in Tunisia.
Reporting to the Quality Systems and Validation Manager you will proactively support the support in the reporting of key quality metrics and coordination of quality systems programs in line with the company strategic plan.
Essential Duties and Responsibilities
<ul>
<li>Timely reporting of all required KPI - Complaints (Daily reports, CIPM, MOST data, monthly complaints meeting)</li>
<li>Maintenance of quality systems related standard operating procedures, ensuring compliance with relevant parent global policies and procedures and applicable regulations.</li>
<li>Support preparation and development of Annual Product Quality reviews and other periodic quality management reviews for post market surveillance and quality systems.</li>
<li>Co-Ordination of Global observation certification program.</li>
<li>Co-Ordination of Global Entity Document Review program</li>
</ul>
Fundamental requirements:
<ul>
<li>Excellent attention to details</li>
<li>Be assertive and proactive</li>
<li>Fluency in written and spoken English</li>
<li>Experience within the pharmaceutical/medical device industry</li>
<li>Experience in a quality function</li>
</ul>


We are looking for Quality System Coordinator to support our Quality team in Tunisia.

Reporting to the Quality Systems and Validation Manager you will proactively support the support in the reporting of key quality metrics and coordination of quality systems programs in line with the company strategic plan.

Essential Duties and Responsibilities


 - Timely reporting of all required KPI - Complaints (Daily reports, CIPM, MOST data, monthly complaints meeting)

 - Maintenance of quality systems related standard operating procedures, ensuring compliance with relevant parent global policies and procedures and applicable regulations.

 - Support preparation and development of Annual Product Quality reviews and other periodic quality management reviews for post market surveillance and quality systems.

 - Co-Ordination of Global observation certification program.

 - Co-Ordination of Global Entity Document Review program


Fundamental requirements:


 - Excellent attention to details

 - Be assertive and proactive

 - Fluency in written and spoken English

 - Experience within the pharmaceutical/medical device industry

 - Experience in a quality function
