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Penzberg - Head of Department Quality Management / Quality Assurance RAS Penzberg (m/f)

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Penzberg - Pharma - Management - Roche

Serve as the Quality Management Representative according to ISO 13485. Provide leadership and coordination in all aspects of QM and QA for RAS Lifecycle Teams and Functions at site Penzberg and DIA Operations Penzberg including qualified guidance and support with regards to all QM/QA related questions. Provide oversight of the local QMS RAS Penzberg, certified according to ISO 13485. Assure compliance with internal requirements (e.g. Roche Policies, Divisional Quality Standards) and applicable external regulations (e.g. ISO 13485, IVDD, GMP,FDA QSReg, German Drug Law). Represent the local QMS in inspections and/or audits conducted by authorities and/or customers; manage required activities for re-certification. Ensure implementation of and compliance with all quality related processes in RAS Lifecycle Teams and Functions at site Penzberg and DIA Operations Penzberg. Monitor efficacy and efficiency and drive continuous improvement of the local QMS and quality related processes through establishing adequate KPIs and QM reporting. Lead, motivate, and develop the Quality Team RAS Penzberg according to their needs and skills.   University degree in natural science e.g. Pharmacy, (Bio-) Chemistry, (Molecular) Biology, with doctor’s degree preferred QM lead auditor qualification Soun ...


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