Batch Record Review Specialist | Spezialist Batch Record Review (w/m/d)
Brunel GmbH NL Mannheim
Job Summary
This role is for a dedicated Batch Record Review Specialist who will be responsible for meticulously reviewing batch documentation for finished pharmaceuticals, bulk goods, and intermediate products, ensuring strict compliance with AMG, AMWHV, GMP, and internal guidelines. The specialist will also handle and evaluate deviations in bulk production and packaging, ensuring all activities are properly documented in a GMP-compliant manner. Key responsibilities include reporting and tracking deviations in SOPs or batch documentation, and conducting and documenting training, line clearances, and GEMBA walks. This position offers a dynamic environment with continuous opportunities for professional and personal development within a growing company, making it an attractive opportunity for professionals seeking new challenges in the pharmaceutical industry.
Required Skills
Education
Completed training in a pharmaceutical, chemical, or biological field (e.g., Pharmaceutical Technician, Chemical Laboratory Assistant, BTA, CTA) or comparable qualification
Experience
- Professional experience in batch documentation review
- Professional experience in GMP-compliant documentation
- Professional experience in the pharmaceutical industry
- Professional experience in handling deviations and quality processes
Languages
Additional
- Not specified
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