Senior Quality Assurance Specialist

1 month ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

Quality Assurance Role in Global Pharmaceutical Network

In this position, you will be responsible for ensuring quality processes in Novo Nordisk's global network of Contract Manufacturer Organizations (CMOs). You will participate in various projects within Active Pharmaceutical Ingredients (API) and starting material, working with both internal and external business partners.

Key Responsibilities:

  • Quality responsibility for technical transfer to CMOs and ensuring compliance with GMP requirements.
  • Negotiation and implementation of quality agreements, approving process validation strategy, and related documents.
  • Manage quality issues during technical transfer, including process validation documentations, deviations, and out-of-specifications.
  • Expected travel of around 20 days per year to CMO locations in Europe and the US.

Requirements:

  • Academic degree in Pharmacy, Engineering, or similar field.
  • Several years of experience in the pharmaceutical industry, either in production or QA.
  • Knowledge of quality, validation, and GMP requirements.
  • Fluency in English.

About the Department:

The GCM QA Drug Substance area is responsible for quality assurance and quality support to outsourced production activities worldwide. The department is characterized by a high level of professionalism, flexibility, and cooperation.



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