Quality Engineer Pharmacy Biotechnology | Qualitätsingenieur Phamazie Biotechnologie (m/w/d)
Brunel GmbH NL Würzburg
Job Summary
This role is ideal for a professional seeking challenging projects in the medical technology sector, focusing on quality assurance within pharmaceutical and biotechnology production. The Quality Engineer will primarily handle deviations and change controls related to the manufacturing, testing, and storage of cell banks, Drug Substance, and Drug Product for proprietary development products. Key responsibilities include representing the Quality department in team rooms concerning deviations and change controls, preparing Product Specification Files, and serving as the main Quality contact for manufacturing areas and the central quality unit. Candidates must possess a degree in Medical Technology or Biology, or equivalent professional experience, coupled with knowledge of GMP regulations and quality processes like Deviation, Investigation, and CAPA. Experience with electronic quality event management systems is beneficial, offering a stable, full-time position with opportunities for career development and training.
Required Skills
Education
Completed degree in Medical Technology, Biology, or equivalent professional training and experience
Experience
- Initial experience in the manufacturing or testing of biological active ingredients/products
- Knowledge of quality processes including Deviation, Investigation, and CAPA
- Initial experience using electronic systems for recording quality events
Languages
Additional
- Not specified
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