Senior QA Specialist
- Coordinate and support the timely, effective and efficient day-to-day operation of assigned Quality Management System activities, in accordance with EU GMP and GDP and prevailing legislation, under the direction of the QMS Manager.
- Support the implementation and maintenance of regulatory compliance, data integrity and quality risk management principles.
- Facilitate the coordination, monitoring and follow-up of Quality Assurance activities, providing technical guidance and support to relevant personnel and departments, and escalating significant issues, as appropriate.
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Coordinate the lifecycle management of QMS documentation, including preparation, review, approval, periodic review and maintenance of controlled documents and records.
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Coordinate and participate in self-inspections and support external audits and inspections, ensuring appropriate follow-up and closure of findings.
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Develop and deliver GMP and Quality-related training, monitor training compliance, and maintain training systems and records.
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Coordinate and monitor quality investigations, review root cause assessments and support the implementation of appropriate corrective and preventive actions (CAPAs).
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Review third-party quality documentation, including Product Quality Reviews, audit reports, licences and certifications, identifying compliance gaps and issues requiring escalation.
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Support the maintenance of regulatory authorisations, the Site Master File and quality policies.
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Identify and coordinate continuous improvement initiatives to enhance QMS effectiveness, compliance and operational efficiency.
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Coordinate the preparation, review, approval and maintenance of Quality Technical Agreements.
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Maintain supplier, customer and item master data in Oracle, ensuring compliance with applicable quality and licensing requirements.
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Coordinate supplier and customer qualification and requalification activities, licence and certification verification, supplier audit planning and follow-up of outstanding actions.
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Monitor CAPA implementation, closure and effectiveness, escalating overdue or ineffective actions as required.
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Coordinate change control processes, assessing quality and regulatory impacts and ensuring timely implementation and closure of approved changes.
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Liaise with relevant departments and external parties to coordinate QMS activities, resolve quality-related issues and ensure compliance with GMP requirements and Company procedures.
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Provide technical guidance on QMS processes and promote consistent application of procedures and quality standards.
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Compile, monitor and analyse QMS performance indicators, identify trends and improvement opportunities, and escalate significant findings.
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Identify compliance risks and escalate significant issues, delays or resource constraints to the QMS Manager.
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Perform other duties commensurate with the role and level of responsibility, as reasonably required.
- Bachelor's degree in Pharmacy (B.Pharm), Science (B.Sc.), or a related discipline.
- 2–5 years of relevant professional experience in Quality Assurance in a cGMP/GDP-regulated environment.
- Fluent in English, both written and spoken.
- Strong analytical, problem-solving, and organisational skills, with excellent attention to detail.
- Ability to work independently, manage priorities effectively and collaborate with and coordinate cross-functional teams.
- Health Insurance
- Gym Benefits
- Hybrid
English
Maltese
