Biochemist or Pharmacist as QC Expert | Biochemiker oder Pharmazeut (m/w/d) als QC Expert
akut... Kompetente Lösungen GmbH
Job Summary
This role is ideal for an experienced scientific professional, such as a Biochemist or Pharmacist, ready to step into a Quality Control (QC) Expert position within the innovative pharmaceutical industry. The QC Expert is responsible for planning and coordinating complex quality control processes for biopharmaceutical products, including material releases, sample management, and stability studies. Day-to-day tasks involve supporting the laboratory head, coordinating analysis documentation for GMP documents, handling deviation and change processes, and creating essential GMP documentation like specifications and reports. A key component is independently responding to internal and external inquiries, interpreting complex test results, and summarizing data for internal use, partners, or regulatory authorities, often in English. The position requires deep expertise in GMP regulations, quality management systems (like Trackwise), and advanced knowledge in sample coordination and stability studies, ensuring compliance across all activities. This is a hybrid role, offering flexibility with remote work up to two days per week, initially on an 18-month contract with the option for permanent employment.
Required Skills
Education
Master of Science in Chemistry, Biochemistry, Pharmacy, or comparable natural science fields; Alternatively, completed vocational training in relevant fields.
Experience
- Several years of professional experience following a natural science degree (Master of Science)
- Extensive relevant professional experience in the pharmaceutical environment (alternative to Master's degree)
- 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
- Initial 18-month fixed-term contract (with option for permanent takeover); Hybrid work model (2 days per week remote/home office possible); Must ensure adherence to GxP and other regulations.
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