Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Join the Thermo Fisher team for impactful work and chances to contribute to the world.
Job Description
Ensure compliance of the Production steps from raw material reception to Drug release, according to cGMP, pharmaceutical regulation in order to ensure the batch availability for patient use.
Responsibilities:
- Ensure compliance of the manufacturing processes, batch record, deviation, change control, CAPA
- Review and approve executed batch records within defined timeline
- Responsible for technical batch release
- Active on-the-floor support
- Review and approval of operational elements such as procedures and related documents including specifications, working instructions, impact assessment.
- 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 proposals to improve flows, manufacturing activities, and organization
Qualifications:
- Pharmacist or scientist with a master’s degree or equivalent experience. At least 3-5 years in the pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes with a focus on biologic drug substances.
- Proficient communication (oral and written) in German and English.
- Experience in SAP and electronic MES (manufacturing execution system) is an asset.
- On-call services, remote, based on department organization.
Join us to help customers globally for a healthier, cleaner, and safer world.
Apply today! http://jobs.thermofisher.com
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
Thermo Fisher Scientific provides accommodations for job seekers with disabilities in the application process. If you need assistance due to hearing, vision, mobility, or cognitive issues, call 1-855-471-2255
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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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