Pharmaceutical Quality Engineer | Qualitätsingenieur (m/w/d) Pharma
FERCHAU GmbH Niederlassung Mannheim
Job Summary
As a Pharmaceutical Quality Engineer, you will play a critical role in ensuring the safety and efficacy of clinical trial products within a GMP-regulated environment. Your daily responsibilities will involve managing complaints, conducting root cause analyses, and coordinating laboratory investigations to implement effective Corrective and Preventive Actions (CAPAs). You will be responsible for maintaining Quality Management System (QMS) documentation, performing pharmaceutical risk assessments, and overseeing product releases. Additionally, you will handle clinical trial applications and submission documents, ensuring that all processes align with design transfer specifications. This role is ideal for professionals looking to work on complex development projects for renowned clients in the Life Sciences sector. Joining this team offers significant growth potential through the in-house academy, a supportive environment with team events, and a comprehensive benefits package including childcare subsidies and specialized training.
Required Skills
Education
Completed university degree in Natural Sciences (e.g., Biology, Chemistry, Pharmacy, or related field).
Experience
- Professional experience within the pharmaceutical industry
- Practical experience in drug development and the management of clinical trial products
- Demonstrated experience in GMP-compliant complaint management and root cause analysis
- Experience in creating and maintaining QMS documentation and clinical submission documents
Languages
Additional
- Familiarity with international pharmaceutical law and Clinical Trial Regulation (CTR) is required.
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