Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob Description
Join Thermo Fisher Scientific Inc., a world-class leader in serving science, as a Senior Scientist QA Operations in our Engineering division. This is an outstanding chance to create a significant impact by ensuring that our pharmaceutical products are produced flawlessly and safely!Responsibilities:- Ensure compliance of the manufacturing processes, batch records, deviations, change controls, and CAPA.
- Review and approve completed batch records within strictly defined timelines.
- Responsible for the technical batch release, ensuring products meet the highest standards.
- Provide active on-the-floor support during critical manufacturing steps.
- Evaluate and sanction operational documents, such as procedures, specifications, and working instructions.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation and execution of the Annual Product Quality Review (APQR).
- Adhere to and promote data integrity rules (ALCOA+).
- Make proposals to improve manufacturing flows, activities, and organization.
- Pharmacist or scientist with a master’s degree or equivalent experience.
- At least 3-5 years in the pharmaceutical industry, with not less than 1 year in commercial batch release.
- In-depth knowledge of pharmaceutical manufacturing processes, especially biologic drug substances.
- Proficient in German and English, with strong communication skills.
- Experience with SAP and electronic MES (Manufacturing Execution System) is an asset.
- Availability for on-call services and remote work as needed.
Be part of an ambitious team that strives for flawless execution and proven results. Apply your expertise to determine and successfully implement quality measures that compete at the highest level in the industry!
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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