We are seeking a QA Project Manager to join our exceptional QA team. In this role, the manager will stay informed about guidance from the FDA/EMA and other regulatory bodies, ensuring continuous compliance and improvement in Quality Assurance activities across the facility. The QA Project Manager will play a crucial role in maintaining operational excellence to support production and product release. Join us in shaping quality standards and driving excellence in our dynamic work environment.
- Release batch records for clinical trials and the commercial market
- Write and update relevant SOPs
- Investigate exceptions
- Manage change controls
- Manage packaging and control lines in production processes.
- Conduct self-inspections
- Write documents such as risk surveys, annual reviews, work procedures, etc.
- Prepare quarterly and annual quality reports
- Collaborate with production, maintenance, laboratories, R&D, etc.
- Education: MSc/ BSc in Pharmacy preferable, Chemistry /Biology /Biotechnology degree
- Candidate should have at least 3 years of experience in a similar position
- Experience in QA in the biotech/pharmaceutical industry (GDP or GMP environment required) – a must
- Background and work experience with the FDA and/or EMA – an advantage
- Fluent in English (speaking, reading, and communicating effectively).
- The job requires a candidate with a scientific mindset, high work ethics, professionalism, the ability to work under pressure within tight timelines, as well as excellent attention to detail and organizational skills.