Quality Engineer, Pharmaceutical | Qualitätsingenieur (m/w/d) Pharma
FERCHAU GmbH Niederlassung Mannheim
Job Summary
This role involves ensuring the quality and compliance of clinical trial preparations within the pharmaceutical and life science sectors. The Quality Engineer will be responsible for GMP-compliant complaints management, conducting root cause analyses, and coordinating laboratory analyses, including the implementation of Corrective and Preventive Actions (CAPAs). Key duties also include creating and maintaining Quality Management System (QMS) documents, analyzing key performance indicators (KPIs) for defect identification, and performing pharmaceutical risk assessments leading to product release. The position requires a completed scientific degree and practical experience in pharmaceutical industry, specifically in drug development and managing clinical trial materials. Expertise in cGMP (EU/US), Clinical Trial Regulation (CTR), and international pharmaceutical law is essential, alongside fluent German and English skills.
Required Skills
Education
Completed scientific degree
Experience
- Professional experience in the pharmaceutical industry
- Practical experience in drug development and management of clinical trial preparations
- Knowledge of cGMP (EU/US) and Clinical Trial Regulation (CTR)
- Knowledge of international pharmaceutical law
Languages
Additional
- Not specified
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