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 of more than 100,000colleagues 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.
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Location/Division Specific Information
Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
You can find out more about our location in Weil am Rhein and Rheinfelden here:www.fisherclinicalservices.com
Discover impactful Work
Under direction of the Quality Assurance Manager, proactively manage the client audit programme, hosting client audits and organize the client audit response. Complete internal audits to detect compliance issues. Complete Quality Assurance review of investigations and approval of completed investigations to ensure compliance to applicable SOPs and that appropriate CAPA have been opened.
A Day in the Life
- Schedule and host client audits
- Participation in health authority inspections
- Complete client audit responses on time
- Plan and perform internal audits to detect compliance issues
- Complete Quality Assurance approval of investigations
- Complete initial quality review of investigations and assign to appropriate investigators Complete other QA activities as requested to support the business
- Approve CAPAs
- Participation in PPI activities.
Education
- Academic degree in a technical field such as pharmacy, natural science, engineering or PTA/MTA/CTA (or equivalent)
- Several years experience in the pharmaceutical industry (Quality Control or Quality Assurance) GxP training or experience
- GMP QA experience
- Audit and inspection experience, preferred
- Knowledge, Skills, Abilities
- Good written and oral English and German skills
- Demonstrated ability to perform detail-oriented tasks
- Strong understanding of EU GMP
- Employment with an innovative, future-oriented organisation
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
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, disability or any other legally protected status.