Specialist Batch Record Review - Pharma | Specialist Batch Record Review - Pharma (m/w/d)

FERCHAU GmbH Niederlassung Ulm

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Sep 26, 2025
Full-time
No information

Job Summary

This role involves ensuring the quality and compliance of biopharmaceutical products by meticulously reviewing batch manufacturing documentation for active ingredients, including in-process testing, in accordance with GMP guidelines and internal SOPs. The specialist will also be responsible for verifying batch-related deviations, clarifying observations with relevant departments, and potentially initiating deviation creation. A key aspect of the role is acting as a point of contact for compliance officers in operations and laboratories, contributing to the timely completion of batch documentation, and supporting release preparations. This position is ideal for a detail-oriented professional with a background in biopharmaceutical manufacturing and a strong understanding of quality standards.

Required Skills

Education

Completed training as a Biology or Chemistry Laboratory Technician, CTA, BTA, or other relevant training, ideally with knowledge in biopharmaceutical active ingredient manufacturing

Experience

  • Professional experience in Batch Record Review (desirable)
  • Experience with GMP and understanding of biopharmaceutical production processes (beneficial)

Languages

Not specified

Additional

  • Not specified