Quality Assurance Expert in the Pharmaceutical Environment | Quality-Assurance-Experte (m/w/d) im Pharma Umfeld
FERCHAU GmbH Wiesbaden Pharma & Life Science
Job Summary
This role involves acting as a Quality Assurance Expert within the pharmaceutical and life science sectors, supporting clients through the entire product lifecycle. Day-to-day responsibilities include managing and executing validations, evaluating deviations, and processing change controls. A key focus is the coordination and documentation of deviations, conducting root cause analysis, tracking resulting corrective and preventive actions (CAPA), and assessing their effectiveness. The expert will be responsible for creating and reviewing GMP-compliant documentation and master documents to ensure adherence to international regulations. Collaboration is crucial, requiring coordination with departments like Regulatory Affairs, Compliance Management, Quality Control, and Engineering. The ideal candidate holds a degree in Natural Sciences, Pharmacy, or Engineering, possesses fundamental knowledge of Quality Assurance under GMP, preferably gained in a manufacturing setting, and must be fluent in both German and English.
Required Skills
Education
University degree in Natural Sciences, Pharmacy, or Engineering
Experience
- Fundamental knowledge in Quality Assurance under GMP
- Professional experience, ideally from a producing operation (manufacturing environment)
Languages
Additional
- Support for specialist departments during authority inspections
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