Batch Record Review Specialist | Spezialist Batch Record Review (w/m/d)
Brunel GmbH NL Mannheim
Job Summary
As a Batch Record Review Specialist, you will be responsible for reviewing batch documentation for finished pharmaceuticals, bulk products, and intermediates in compliance with AMG, AMWHV, GMP, and internal standards. Your daily tasks include processing and evaluating deviations in bulk production and packaging, ensuring GMP-compliant documentation, reporting and tracking deviations in SOPs or batch records, and conducting training, line clearances, and GEMBA walks. The role requires a completed vocational training in pharmaceutical, chemical, or biological fields (e.g., pharmaceutical technician, chemical laboratory assistant, BTA, CTA) or equivalent qualification, experience in batch documentation review and GMP-compliant documentation, knowledge of relevant regulations, and professional experience in the pharmaceutical industry with deviations and quality processes. This position offers a permanent contract, 30 vacation days, employer-funded pension, and opportunities for individual training and development in a growing company.
Required Skills
Education
Completed vocational training in pharmaceutical, chemical, or biological field (e.g., pharmaceutical technician, chemical laboratory assistant, BTA, CTA) or equivalent qualification
Experience
- Experience in reviewing batch documentation
- Experience with GMP-compliant documentation
- Professional experience in the pharmaceutical industry
- Experience handling deviations and quality processes
Languages
Additional
- Not specified
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