Advanced Quality Assurance Professional

3 days ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

At Novo Nordisk A/S, we are seeking an Advanced Quality Assurance Professional to join our Global Contract Manufacturing team.

Job Description
  • The selected candidate will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).
  • This involves overseeing the quality processes of our CMOs for Active Pharmaceutical Ingredients (API) and Drug Substance (DS).
  • The role requires close collaboration with internal and external business partners and a high level of complexity in daily tasks.

The QA role includes:

  • Ensuring that our products are manufactured according to cGMP and our Marketing Authorizations.
  • Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks.
  • Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs.
  • QA support and GMP guidance to our partners and final release of the products from CMOs to the further process in Novo Nordisk.
  • Expected travel is around 10-15 days a year as the CMOs are located outside Denmark primarily Europe and US.

If you are looking for a challenging role which can foster the development of your professional and personal competences, this is your opportunity.

Required Skills and Qualifications

  • Hold an academic degree as Pharmacist, Engineer or similar.
  • Possess a minimum of three years of experience in the pharmaceutical industry, preferably in production or QA.
  • Have gained a solid and up-to-date knowledge of quality and GMP requirements.
  • Have great communication and collaboration skills and speaks and writes English fluently.

About The Department

The GCM Drug Substance QA area is responsible for quality assurance and quality support to outsourced production activities worldwide.

GCM DS QA is a dynamic area consisting of around 50 competent people with focus on either operations or projects. The department is characterized by a high level of professionalism, flexibility, and cooperation.

We focus on good social relations and prioritize to make room for fun at work. We have a great team spirit, and it is important for us that you will be a part of it.



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