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Senior QA Scientist is part of the QA Operations team at our new Lengnau facility. This person’s core responsibility lies in the governance of material management processes including batch disposition and review of associated documents to ensure all requirements and specifications are met.
During ramp up of the facility, the role plays a key part in conceptual evaluation and implementation of key QA processes and additionally provide QA support and mentorship to related functional departments.
Main Responsibilities
- In project phase: Responsible for the implementation of a Good Manufacturing Practices (GMP) Manufacturing Execution System (MES) – including implementation of the concept 'Review by Exception'.
- Coordinates and performs the review of Master and completed Batch Records (BRs) for compliance to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP) and Quality Assurance (QA) standards.
- Release of purchased materials, internally manufactured materials including buffer/media/assemblies, and intermediates in compliance to GMP.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervision of the preparation of the Annual Product Review and guarantees its execution within the due date.
Education
- Bachelor's or Master's Degree in Natural Science field (i.e. Chemistry, Biology, Biotechnology etc)
Experience and Competences
- At least 3 years working experience in pharmaceutical industry
- At least 1 year working experience in commercial batch release
- Knowledge of fundamentals and processes of pharmaceutical manufacturing processes encouraged
- Proficient communication (oral and written) in German and English.
- Knowledge or any experience with SAP will be an asset, comfort with electronic batch records preferred.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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