Senior Batch Record Specialist | Senior Batch Record (w/m/d)

Brunel GmbH NL Mannheim

Mannheim, Baden-Württemberg, Deutschland
Published Apr 9, 2026
Full-time
Permanent

Job Summary

As a Senior Batch Record Specialist, you will be responsible for the meticulous review and processing of batch documentation within a high-stakes pharmaceutical environment. Your daily activities will focus on ensuring full compliance with Good Manufacturing Practice (GMP) guidelines and meeting order lead times. You will oversee manufacturing instructions, coordinate corrections across production units, and support critical GMP audits and inspections. This role is central to quality assurance, involving the creation of Standard Operating Procedures (SOPs), conducting staff training, and leveraging electronic systems like MES and SAP to analyze batch data for process optimization. A unique aspect of this position is the opportunity to contribute to the implementation of new Electronic Batch Record (EBR) systems. This is an attractive permanent role for a professional looking to combine technical pharmaceutical expertise with process improvement and cross-departmental coordination in a supportive corporate culture.

Required Skills

Education

Master's degree in Biotechnology or a comparable field of study.

Experience

  • Several years of professional experience in the production of parenterals
  • Extensive experience in GMP-compliant documentation and hygiene standards within the pharmaceutical industry
  • Proven experience in coordinating with production units and managing backlogs
  • Experience in supporting GMP audits and regulatory inspections
  • Professional experience in creating and conducting employee training

Languages

German (Fluent)English (Basic)

Additional

  • Must have the ability to work full-time on an unlimited (permanent) contract. Role involves cross-departmental coordination and potential involvement in system implementation projects.