Batch Record Review Specialist | Specialist* Batch Record Review - Roche Mannheim
Franz & Wach Personalservice PEN
Job Summary
As a Batch Record Review Specialist at Roche Diagnostics in Mannheim, you will play a critical role in ensuring GMP compliance within pharmaceutical production. Your daily responsibilities include reviewing batch records for accuracy, tracking documentation corrections, managing order lead times, and supporting GMP audits. You will also contribute to process improvements, assist in the implementation of new electronic batch record (EBR) systems, and conduct training on documentation-related SOPs. This position is ideal for a professional with a strong background in life sciences or engineering who is passionate about quality assurance and process optimization. You will work in a dynamic environment where you act as a key interface between production units and quality departments, ensuring that all documentation meets strict regulatory standards while actively participating in continuous improvement initiatives.
Required Skills
Education
Completed Bachelor's degree in a scientific field (Pharmacy, Biology, Engineering, or similar) OR a technical/scientific vocational qualification (Master Craftsman/Technician degree).
Experience
- Extensive professional experience in a GMP production environment
- Several years of experience in a comparable role
- Significant experience in processing complex product forms, specifically sterile products or biological drugs
Languages
Additional
- Valid work permit for Germany required. Specific certifications in Good Manufacturing Practice and Batch Record Review are considered an advantage.
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