APL Swift Services

Aurobindo Pharma (Malta) Limited is a fully owned subsidiary of Aurobindo Pharma Pvt Ltd from Andhra Pradesh India, and is Asia’s largest generic pharmaceutical and API manufacturer, and among the major ‘vertically integrated’ pharmaceutical companies in India, exporting to over 125 countries across the globe. Aurobindo Pharma (Malta) Limited is the gateway for Aurobindo’s pharmaceutical products in Europe. The Malta operations commenced in 2008 offering Analytical Services, Batch Release, Warehousing including Logistics at a pan European level.

About

EU Quality Assurance Officer

Assists the European Quality Manager in the day-to-day operation and management of the quality system according to EU GxP requirements
Assists the European Quality Manager in the upkeep of the Regulatory Compliance.
Maintenance and management of all GxP documentation pertaining to CMOs.

Main tasks and responsibilities

Support manager in the management of all CMO relations including:
Quality Management Systems such as Complaints, Deviations, PQR, Change Controls, TA’s and CAPA’s.
Follow up on Supplier audits and qualification system.
Support EU Quality team in relation to EMA requirements.
Overseeing Quality tracker Metrics of the European Aurobindo Affiliates.
Supporting with performing audit of the European Aurobindo Affiliates.
Carry out other duties as required.

Educational and skill requirements

Bachelor's degree in Life Sciences, Pharmacy, Chemistry or a related discipline.
1–3 years' experience in a pharmaceutical Quality Assurance or GxP environment.
Basic knowledge of EU GxP requirements and Quality Management Systems.
Experience with quality processes such as deviations, CAPAs, change controls, complaints, or document management is an advantage.
Good organisational skills with the ability to coordinate and follow up on multiple activities.
Strong communication skills and ability to work effectively with colleagues and across different countries.
Proficient in Microsoft Office; experience with electronic Quality Management Systems is an advantage.
Fluent in English, both written and spoken.

Job benefits