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 the GMP-compliant documentation of pharmaceutical production processes. Your daily responsibilities include the meticulous review of batch records (HABs), verifying documentation for accuracy, and ensuring strict adherence to Order Lead Times (OLT). You will act as a key interface between production and quality, tracking deviations, conducting audits, and updating Standard Operating Procedures (SOPs). Beyond administrative review, you will engage in process optimization, trend analysis for alarms, and the implementation of electronic batch record (EBR) systems. This position is particularly attractive for professionals seeking to work within a world-leading diagnostic environment, offering a high-impact role in quality assurance where you can contribute to continuous improvement projects (KVP) and present documentation during international inspections.
Required Skills
Education
Successfully completed Bachelor's degree in a scientific field (Pharmacy, Biology, Engineering, or equivalent) or a scientific/technical vocational qualification (Master Craftsman/Technician level).
Experience
- Long-term professional experience in a GMP production environment or several years of experience in a comparable quality assurance position
- Extensive experience in processing complex product forms such as sterile products or biological medicinal products
- Experience in identifying and analyzing trends in process data and statistical concepts
- Experience in collaborating on cross-functional continuous improvement projects
Languages
Additional
- Must be able to present documentation and processes during audits and inspections in English. Specific certifications in GMP and Batch Record Review are preferred. The position is a full-time, fixed-term contract via employee leasing.
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