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How will you make an impact?
With 70000 extraordinary minds on our global team, each one of us at Thermo Fisher has an important story to tell. Whether we’re helping customers to fight disease, making sure our air is clean, or solving cold cases, our stories involve thousands of important projects that improve millions of lives. Our dedicated sales professionals are laser focused on delivering our customer value proposition-accelerating innovation and enhancing productivity. With talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.
What you will do?
You will be responsible for managing client audits and ensuring compliance to regulations. You will facilitate and provide support for client and government audits according to HPFBI/FDA and other agency regulations.
- Conduct internal GMP audits and host audits.
- Assess the compliance of new/renovated areas of the facility.
- Maintain records and follow-up files
- Manage audit responses and CAPA closures
- Support FDA, HPFBI and other regulatory authority audits
- Problem solve and troubleshoot issues regarding GMP compliance and audit follow-up and closure
- Manage specialized projects and duties pertaining to Quality Operations as required
How will you get here?
- Minimum Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related field or College Diploma with related experience
- Minimum 5 years GMP auditing experience in the pharmaceutical industry with experience in material handling, sanitation and pharmaceutical production and packaging processes
- Ability to assess observation responses and CAPA closure activities
- Exceptional Good Manufacturing Practices, and HPBI/FDA compliance knowledge
- Good computer skills including Excel, Word and Access
- Excellent interpersonal, oral and written communication skills
- Knowledge of laboratory testing and equipment techniques
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
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