Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Join Thermo Fisher Scientific Inc. for an exceptionally rewarding career where your contributions help craft the future of science and health!Responsibilities:- Ensure compliance of the manufacturing processes, batch record, deviation, change control, and CAPA.
- Review and approve completed batch records within defined timelines.
- Responsible for technical batch release.
- Provide active on-the-floor support to the production team.
- Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the due date.
- Be present on the floor during critical manufacturing steps.
- Uphold and share data integrity rules (ALCOA+).
- Propose improvements to flows, manufacturing activities, and organizational processes.
- Seeking pharmacists or scientists with a master's degree or equivalent experience. Requires 3-5 years in pharma (biotech) and 1 year in commercial batch release.
- In-depth knowledge of pharmaceutical manufacturing processes, particularly biologic drug substances.
- Strong oral and written communication skills in English; proficiency in German of advantage
- Experience with SAP and electronic MES (manufacturing execution system) is a plus.
- Ability to provide on-call services remotely based on departmental needs.
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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