Senior Batch Record Specialist | Senior Batch Record (w/m/d)
Brunel GmbH NL Mannheim
Job Summary
As a Senior Batch Record Specialist, you will play a critical role in the pharmaceutical production process by ensuring the integrity and compliance of batch documentation. Your daily responsibilities include reviewing and processing batch records in accordance with strict GMP guidelines and lead time requirements. You will coordinate corrections with production departments, manage Manufacturing Instructions (HABs), and support GMP audits and inspections. Beyond documentation, you will be instrumental in process optimization, identifying improvements through electronic data analysis, and assisting in the implementation of new Electronic Batch Record (EBR) systems. This role is highly collaborative, requiring you to act as a cross-functional interface to reduce backlogs and improve workflows. The position is ideal for professionals with a background in biotechnology who value a structured yet evolving environment. Brunel offers a supportive culture with permanent contracts, 30 days of vacation, and comprehensive professional development opportunities, making this a stable and rewarding career move for quality-focused experts.
Required Skills
Education
Master's degree in Biotechnology or a comparable field of study.
Experience
- Several years of professional experience in the manufacturing of parenterals
- Extensive experience in GMP-compliant documentation and hygiene standards within a pharmaceutical environment
- Proven experience in managing manufacturing instructions and coordinating with production facilities
- Experience in supporting GMP audits and regulatory inspections
- Professional experience in training staff and creating SOPs
Languages
Additional
- Must have the ability to work at the specified location; position involves a permanent full-time contract.
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