Senior Quality Assurance Specialist
3 weeks ago
Are you looking for a challenging role in quality assurance where you can make a significant impact in Novo Nordisk's global network of Contract Manufacturer Organizations (CMOs)?
About the RoleIn this position, you will be responsible for ensuring the quality of product transfers from Novo Nordisk to Contract Manufacturing Organizations (CMOs). You will work closely with internal and external business partners to ensure compliance with relevant GMP requirements.
Key Responsibilities- Ensure the quality responsibility for technical transfers to CMOs and lead the implementation of quality agreements.
- Negotiate and implement quality agreements, approve process validation strategies, and related documents.
- Manage quality issues during technical transfers, including process validation documentations, deviations, out of specifications, change controls, and action plans.
- Participate in qualification audits performed at CMOs and ensure sufficient follow-up on CAPAs.
- An academic degree in a relevant field, such as pharmacy or engineering.
- A few years of experience in the pharmaceutical industry, either in production or QA.
- Knowledge of quality, validation, and GMP requirements.
- Fluency in English.
The GCM QA Drug Substance area is responsible for quality assurance and quality support to outsourced production activities worldwide. We are a dynamic team of 35 competent people divided into 4 teams and departments, with a focus on either operations or projects.
Working at Novo NordiskWe are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work.
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