Non-Conformity Manager, Quality Control | Non-Conformity Manager (m/w/d) Quality Control
Biotest AG
Job Summary
As a Non-Conformity Manager in Quality Control, you will be responsible for independently conducting, coordinating, and documenting complex GMP-compliant investigations, risk assessments, and necessary measures related to non-conformities. This involves making decisions on immediate actions for affected batches or systems, developing and tracking resulting CAPA measures, and leading interactions with subject matter experts. A key part of the role is ensuring the achievement of Quality Metrics goals and presenting non-conformities and CAPAs during national and international inspections and audits. You will also drive process and quality improvements to prevent future non-conformities and conduct regular process reviews. This position requires a strong background in a GMP-regulated environment, excellent knowledge of pharmaceutical operations and cGMP guidelines, and experience with inspections and risk analysis tools. It offers a chance to contribute to saving lives by ensuring product quality in a global immunology and hematology specialist company.
Required Skills
Education
Completed scientific degree in Biology, Chemistry, Pharmacy, or comparable engineering fields, or equivalent qualification.
Experience
- Several years of experience in a GMP-regulated environment
- Inspection and project experience
- Professional experience in drafting authority-compliant reports
Languages
Additional
- Not specified
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