GMP Assurance Manager Plasma, Quality Operations | GMP Assurance Manager Plasma (m/w/d) Quality Operations
Biotest AG
Job Summary
This role involves ensuring quality assurance and implementing assigned Quality Management (QM) systems, specifically focusing on supplier management, lookback processes, and plasma safety. The manager will be responsible for risk and change management, process optimization, and establishing new processes in line with evolving requirements. Key responsibilities include creating and approving GMP-relevant documents, conducting national and international external audits, and actively participating in projects. The ideal candidate will have a background in biology, chemistry, medicine, or pharmacy, with significant professional experience in the pharmaceutical GMP sector, excellent knowledge of current GMP guidelines, and proficiency in SAP. This position offers an opportunity to contribute to life-saving missions within a global immunology and hematology specialist, providing a supportive work environment and professional development.
Required Skills
Education
University degree in Biology, Chemistry, Medicine, Pharmacy, or a related engineering discipline
Experience
- Several years of professional experience in the pharmaceutical GMP sector
- Experience interacting with national and international authorities
Languages
Additional
- Willingness to travel approximately 15-20%
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