Senior Specialist, Batch Record Review | Sneior Specialist * Batch Record Review - Roche Mannheim
Franz & Wach Personalservice PEN
Job Summary
This role offers an exciting opportunity for a Senior Specialist in Batch Record Review to join Roche Diagnostics GmbH in Mannheim, Germany, through Franz & Wach. The specialist will be responsible for meticulously reviewing batch records, ensuring strict adherence to GMP guidelines, and managing deviations, CAPAs, and process changes within electronic systems like Veeva. Key responsibilities include conducting root cause analyses, implementing corrective actions, and coordinating changes to maintain high-quality documentation. The position also involves supporting GMP audits, contributing to process optimization initiatives, and providing training on documentation-related SOPs. This role is ideal for a detail-oriented professional with a strong background in pharmaceutical manufacturing and a commitment to continuous improvement in a highly regulated environment.
Required Skills
Education
Bachelor's degree in Biotechnology or a comparable field. Master's degree is desirable.
Experience
- Professional experience in Parenteral manufacturing
- Experience in handling deviations
Languages
Additional
- Not specified
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