Sr Scientist QA Operations
vor 6 Monaten
**Work Schedule**
Other
**Environmental Conditions**
Office
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
As part of the QA Operations Team of Fisher Clinical Services GmbH, Lengnau (LGN), the position holder is responsible to review and release recombinant Drug Substance including purchased material, internally manufactured material and intermediates. During the period of establishing the new manufacturing site, the position holder will be part of the facility program and will have to support the implementation of the necessary systems within the facility. In particular the position holder will have support different departments (such Manufacturing, Quality Control, Supply Chain, Engineering).
**Operational axis**:
- During Project Phase: Implementation of Manufacturing Execution System (MES) with regards to QM processes, including ‘Review by Exception’ concept
- Review and approval of operational elements such as procedures and related documents including specifications
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date.
- Be on the floor during critical manufacturing steps
- Respect and share data integrity rules (ALCOA+)
- Make proposal to improve flows, manufacturing activities and organisation
**Background and skills**:
Pharmacist, scientific with master degree or higher. At least 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
Knowledge of pharmaceutical manufacturing processes with particular on biologic drug substance
Fluent communication (oral and written) in German and English.
Experience in SAP and electronic MES (manufacturing execution system) is an asset.
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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