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Advanced Quality Assurance Specialist

2 months ago

Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk Full time

About the Role

We are seeking an experienced Advanced Quality Assurance Professional to join our team at Novo Nordisk. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our pharmaceutical products.

Key Responsibilities

  • Review and approve batch documentation, SOPs, and deviations to ensure compliance with regulatory requirements.
  • Act as a Quality Person delegate, releasing batches for the market after production is complete.
  • Provide QA presence on production lines, observing processes and helping to resolve issues in real-time.
  • Advise stakeholders on maintaining the right level of quality in production processes.
  • Participate in and present cases during inspections from regulatory authorities.
  • Improve processes within the QA area to ensure efficiency and effectiveness.

Requirements

  • An academic degree in a relevant field, such as pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, or technology.
  • At least 2 years of experience in QA or a related GMP role, such as GMP Coordinator.
  • The ability to make decisions based on GMP knowledge and experience.
  • Fluency in written and spoken English.

About the Department

Our Biotech & Rare Disease Quality Assurance Finished Products department is a dynamic and innovative team that sets the direction for quality and compliance in our production processes. We work closely with production and stakeholders to ensure that our products meet the highest standards of quality and safety.

Working at Novo Nordisk

We are a global company dedicated to improving the lives of people with diabetes and other chronic diseases. We offer a collaborative and inclusive work environment, with opportunities for professional and personal growth.