Senior Specialist, Batch Record Review | Sneior Specialist * Batch Record Review - Roche Mannheim
Franz & Wach Personalservice PEN
Job Summary
As a Senior Specialist for Batch Record Review, you will play a crucial role in ensuring the quality and compliance of pharmaceutical manufacturing processes at Roche Diagnostics GmbH in Mannheim. Your daily tasks will involve processing deviations, CAPAs, and process changes, including conducting impact and root cause analyses using electronic systems like Veeva. You will be responsible for the operational review of batch records, meticulously checking documentation for GMP compliance, and ensuring timely corrections. Additionally, you will support GMP audits, contribute to process optimizations, and coordinate batch reviews across various interfaces. This role offers an attractive opportunity to apply your expertise in parenterals manufacturing and GMP regulations within a leading pharmaceutical company, with a focus on continuous improvement and maintaining high documentation standards.
Required Skills
Education
Bachelor's degree in Biotechnology or a comparable field. Master's degree desirable.
Experience
- Professional experience in parenterals manufacturing
- Experience in processing deviations
- Professional experience with GMP regulations and documentation
- Professional experience with IT systems (MES, SAP, Excel, Word, Veeva)
Languages
Additional
- Not specified
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