Specialist Batch Record Review - Pharma | Specialist Batch Record Review - Pharma (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This role involves ensuring the quality and compliance of biopharmaceutical products by meticulously reviewing batch manufacturing documentation, including in-process testing, for active pharmaceutical ingredients. The Specialist will be responsible for verifying adherence to GMP standards and internal Standard Operating Procedures (SOPs), investigating batch-related deviations, and clarifying observations with relevant departments. This position requires a detail-oriented professional capable of managing documentation deadlines and acting as a key contact for compliance officers. The ideal candidate will bring their expertise to a team-oriented environment, contributing to the timely completion of batch documentation and supporting the preparation for product release, all while developing innovative solutions in the pharmaceutical and life sciences sector.
Required Skills
Education
Completed vocational training as a Biology Laboratory Technician, Chemistry Laboratory Technician, Chemical Technical Assistant (CTA), or Biological Technical Assistant (BTA), or other relevant training.
Experience
- Professional experience in biopharmaceutical active ingredient manufacturing is beneficial
- Experience in Batch Record Review is desirable
- Professional experience with GMP standards
Languages
Additional
- Not specified
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