Sr Scientist QA Operations
vor 4 Wochen
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
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Sr Scientist QA Operations
vor 3 Wochen
Lengnau, Schweiz Thermo Fisher Scientific VollzeitAt Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19...
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Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitAt Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions....
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