Quality Control Expert | QC Expert | M/W/D - Referenz 001051
consult16 GmbH
Job Summary
This is a critical 18-month fixed-term role within an internationally successful pharmaceutical company, focusing on the quality control of biopharmaceutical products. The QC Expert is responsible for the comprehensive planning and coordination of complex QC processes, including material releases, sample management, and stability studies. A core duty involves supporting the laboratory leader in planning and evaluating QC activities and coordinating extensive GMP documentation, managing complex deviation and change control procedures, and ensuring strict adherence to GxP regulations. The role requires the independent interpretation and presentation of complex experimental results to internal stakeholders, partners, or regulatory authorities, often in English. Candidates must hold a Master of Science degree in a natural science field (e.g., Chemistry, Pharmacy) or equivalent long-term professional experience, coupled with expert knowledge in GMP, Quality Management Systems (like Trackwise), and analytical documentation. The position offers a hybrid work model, allowing up to two days of remote work per week after initial on-site training in Biberach.
Required Skills
Education
Master of Science in Chemistry, Biochemistry, Pharmacy, or comparable natural science fields; alternatively, completed vocational training in relevant fields with long-term experience.
Experience
- Several years of professional experience in the pharmaceutical environment (required with Master's degree)
- Long-term relevant professional experience in the pharmaceutical environment (required with vocational training)
- In-depth knowledge of the GMP environment
- Practical experience with material releases and/or analytical issues
- Practical experience with Quality Management Systems (e.g., Trackwise)
- Expert knowledge in Sample Coordination/Management, Stability Studies, and Document Management
Languages
Additional
- The position is initially fixed-term for 18 months. Work location is Biberach (Upper Swabia). The role operates under a hybrid model allowing up to two days of remote work/Home Office, but important on-site presence appointments must be maintained. The position is offered through temporary employment (ANÜ).
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