Manager Quality Assurance Qualification / Validation | Pharmazeut (m/w/d)
BioNTech SE
Job Summary
This full-time role in Idar-Oberstein, Germany, focuses on ensuring all requirements and standards for the qualification and validation of equipment and computerized systems are met within a biotechnological/pharmaceutical environment. The successful candidate will be responsible for the formal and technical review of qualification and validation documents, including risk analyses, protocols, reports, and SOPs. Daily tasks involve evaluating information for process and equipment changes, participating in investigations, assessing CAPA, deviations, and changes, and making decisions regarding the closure of actions. This position requires strong collaboration skills, both within QA and cross-departmentally, excellent GxP/GMP knowledge, and proficiency in both German and English, making it ideal for a detail-oriented professional ready to take the next step in pharmaceutical quality assurance.
Required Skills
Education
Relevant university degree (Hochschulausbildung)
Experience
- Minimum 2 years of relevant professional experience in the biotechnological or pharmaceutical industry
- Task-specific professional knowledge and experience in plant qualification
- Experience in conducting risk assessments, root cause analyses, and deviation investigations
- Experience with Change Control and CAPA processes
- Experience with electronic document management systems or other computerized systems (Advantageous)
Languages
Additional
- Not specified
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