Senior Specialist Quality Control (Biopharma) | Biotechnologe (m/w/d) Pharmatechniker (m/w/d) Senior Spezialist Qualitätskontrolle (m/w/d)
agento PersonalManagement GmbH
Job Summary
This Senior Specialist role involves taking responsibility for the planning and coordination of complex Quality Control processes for various biopharmaceutical products. Key daily tasks include managing material releases, overseeing sample management, coordinating stability studies, and supporting the laboratory head in evaluating relevant QC activities. A critical component of the role is coordinating the analysis documentation of various GMP documents, including handling complex deviation and change control processes, and creating detailed work instructions. The specialist will also independently respond to internal and external inquiries, interpreting complex test results, and compiling reports for internal use, partners, or regulatory authorities, often in English. Success requires a strong background in natural sciences (Master's degree or equivalent vocational training) coupled with extensive professional experience, expert knowledge of GxP/GMP regulations, and practical experience with quality management systems like Trackwise. This position offers the opportunity to join a globally recognized pharmaceutical leader in Biberach with a hybrid work model.
Required Skills
Education
Master of Science degree in Chemistry, Biochemistry, Pharmacy, or related natural science fields; or relevant vocational training.
Experience
- Several years of professional experience following a Master of Science degree in natural sciences.
- Long-term relevant professional experience in a pharmaceutical environment (alternative to degree).
- In-depth practical experience with GMP, material releases, and analytical issues.
- Practical experience with Quality Management Systems (e.g., Trackwise).
- Expert knowledge in Sample Coordination/Management, Stability Studies, and documentation management.
Languages
Additional
- Must be able to work independently, meticulously, and highly organized under performance and deadline pressure. Position is based in Biberach with hybrid work model availability (up to 2 days remote) after initial onboarding.
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