Senior Specialist, Quality Control (Biotechnology/Pharmaceutical) | Biotechnologe (m/w/d) Pharmatechniker (m/w/d) Senior Spezialist Qualitätskontrolle (m/w/d)
agento PersonalManagement GmbH
Job Summary
This is a critical role for a Senior Specialist in Quality Control within the biopharmaceutical sector, located in Biberach, offering a hybrid work model (up to two days remote). The specialist will be responsible for planning and coordinating complex QC processes for biopharmaceutical products, including material releases, sample management, and stability studies. Key daily tasks involve supporting the laboratory head, coordinating extensive analysis documentation, managing complex deviation and change control procedures, and ensuring strict adherence to GxP regulations. The role requires the creation of essential GMP documents, specifications, and reports, often for internal use, partners, or regulatory authorities, sometimes in English. Candidates must possess a Master of Science in a natural science field (e.g., Chemistry, Pharmacy) or equivalent professional training, coupled with extensive professional experience, deep GMP knowledge, and expertise in quality management systems like Trackwise. Success requires strong organizational skills and fluency in both German and English.
Required Skills
Education
Master of Science degree in Chemistry, Biochemistry, Pharmacy, or comparable natural science fields; or equivalent completed vocational training with extensive relevant professional experience.
Experience
- Several years of professional experience in the pharmaceutical environment.
- Fundamental knowledge and practical experience in the GMP environment.
- Practical experience with material releases and/or analytical issues.
- Practical experience utilizing Quality Management Systems (e.g., Trackwise).
- Expert knowledge in Sample Coordination/Management, Stability Studies, and Document Management.
Languages
Additional
- Permanent contract; Hybrid work model (up to 2 days remote/home office after onboarding); Ability to work independently, meticulously, and under success and deadline pressure.
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