Senior Quality Assurance Professional in CMC API QA
2 weeks ago
Job Description
Job Summary
We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.
Key Responsibilities
• Ensure best-in-class quality assurance of our API for clinical trials in phase I, II and III testing.
• Challenge and approve documents related to the development, manufacture, stability, and status assignment of internal and external produced API.
• Ensure that our products used in clinical trials are following the information provided to Health Authorities worldwide.
• Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
Requirements
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems.
To succeed in this role, you should:
- Hold a Master in Pharmacy, Engineering, Biology, Chemistry or similar to fulfil the requirements to become a "Qualified Person" (QP), according to The Danish Medicines Agency certification.
- Have extensive experience in a pharmaceutical company, ideally also in a QA role.
- Possess a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production, and hence can navigate without adding complexity.
- Be proficient in English and Danish.
- Proficiency in SAP and/or PasX along with experience with API and CMOs, will be seen as an advantage.
About the Department
CMC API QA is a department which employ 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for all clinical trials within Novo Nordisk. We also have the responsibility of releasing API from contract manufacturers across the globe.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the PositionWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.Key ResponsibilitiesEnsuring best-in-class...
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team as a QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.Key Responsibilities:Ensuring best-in-class quality assurance of our API for clinical...
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