Senior Batch Record Specialist | Senior Batch Record (w/m/d)
Brunel GmbH NL Mannheim
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
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.
More Jobs from Brunel GmbH NL Mannheim
PMO Manager Engineering Projects | PMO Manager Engineering Projects (w/m/d)
May 21, 2026
As a PMO Manager for Engineering Projects, you will play a crucial role in supporting and steering c...
Senior PMO Manager Transformation & Engineering | Senior PMO Manager Transformation & Engineering (w/m/d)
May 21, 2026
As a Senior PMO Manager for Transformation & Engineering, you will be instrumental in strategically ...
Senior Biostatistician / Data Scientist | Senior Biostatistician / Data Scientist (w/m/d)
May 19, 2026
This role offers an exciting opportunity for a Senior Biostatistician/Data Scientist to advance thei...