Pharmaceutical Batch Record Review Specialist | Specialist Batch Record Review - Pharma (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
As a Pharmaceutical Batch Record Review Specialist, you will play a critical role in ensuring regulatory compliance and quality assurance within a biopharmaceutical production environment. Your daily responsibilities include the meticulous review of batch manufacturing documentation for active ingredients, conducting in-process testing reviews, and verifying compliance with Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOP). You will act as a key liaison between operational departments and laboratories, resolving documentation discrepancies, initiating deviation reports when necessary, and coordinating the timely completion of batch records to meet release schedules. This position offers an attractive performance-based salary and significant opportunities for professional growth within a collaborative team environment at FERCHAU. It is an ideal role for detail-oriented professionals who enjoy ensuring high standards of quality in life-saving pharmaceutical production.
Required Skills
Education
Completed vocational training as a Biology or Chemistry Laboratory Technician, CTA, BTA, or an equivalent qualification in a relevant scientific or technical field.
Experience
- Professional experience in biopharmaceutical active ingredient manufacturing or a related laboratory environment
- Practical experience in Good Manufacturing Practice (GMP) and understanding of production processes
- Previous experience in Batch Record Review is highly desirable
- Proven experience using specialized industry systems such as BioMES, SAP Labware, or Idea for Con
- Demonstrated experience in coordinating documentation timelines and cross-departmental communication
Languages
Additional
- Must be able to work independently with high precision and diligence; requires strong communication skills for interdisciplinary coordination with compliance officers and production departments.
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