Manager Quality Assurance Qualification / Validation | Pharmazeut (m/w/d)
BioNTech SE
Job Summary
This Quality Assurance role focuses on ensuring all regulatory requirements and standards for the qualification and validation of equipment and computerized systems are strictly met within the biotechnological or pharmaceutical industry. Key daily tasks include the formal and substantive review of qualification and validation documents, such as risk analyses, protocols, reports, and SOPs. The incumbent will also evaluate information related to process and equipment changes, participate in investigations, and assess corrective actions (CAPA, Deviations, Changes) to authorize their closure. This position requires strong collaboration skills for internal QA alignment and cross-departmental coordination on content issues, planning, and prioritization. Candidates must possess a relevant university degree, at least two years of professional experience in the field, and deep knowledge of GxP regulations, particularly GMP.
Required Skills
Education
Relevant university degree (e.g., Pharmacy, Biotechnology, or equivalent)
Experience
- Minimum 2 years in the biotechnological or pharmaceutical industry
- Professional experience in plant/equipment qualification
- Experience in conducting risk assessments, root cause analyses, and deviation investigations
- Experience with Change Control and CAPA processes
Languages
Additional
- Not specified
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