Specialist Batch Record Review - Pharma | Specialist Batch Record Review - Pharma (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
As a Specialist Batch Record Review in Pharma, you will play a crucial role in ensuring the quality and compliance of biopharmaceutical products. Your day-to-day responsibilities will involve meticulously reviewing batch manufacturing documentation for active ingredients, including in-process testing, to ensure adherence to GMP and internal SOPs. You will also be responsible for reviewing batch-related deviations, clarifying observations with technical departments, and potentially initiating deviation creation. This role requires strong organizational skills to coordinate the timely completion of batch documentation and support release preparations. The ideal candidate will have a background in biology or chemistry, experience with GMP, and a keen eye for detail, contributing to innovative solutions within the pharmaceutical and life science sector.
Required Skills
Education
Completed training as a Biology or Chemistry Laboratory Technician (CTA, BTA), or other relevant qualification
Experience
- Experience in Batch Record Review is desirable
- Professional experience in biopharmaceutical active ingredient manufacturing is ideal
- Experience with GMP and understanding of biopharmaceutical production processes is beneficial
Languages
Additional
- Not specified
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