Advanced Quality Assurance Specialist

2 months ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk Full time

About the Role

As an Advanced Quality Assurance Specialist, you will become part of a competent team responsible for setting direction for quality and compliance due to internal and external requirements and releasing batches for the market.

Main Responsibilities

  • Reviewing batch documentation, SOPs, and deviations to ensure compliance
  • Assuming the role of Quality Person delegate, releasing batches after production completion
  • Providing QA presence on production lines during production to observe processes and resolve issues in real-time
  • Advising stakeholders to maintain the right level of quality in production processes
  • Participating in and presenting cases during inspections from authorities worldwide
  • Improving processes in the QA area

Qualifications

  • An academic degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, or technology or biology
  • 2+ years of experience in QA or a relevant GMP-related role, such as GMP Coordinator
  • The ability to make decisions based on GMP knowledge and experience
  • Fluency in written and spoken Danish and English
  • An eye for detail, dedication, and engagement, with strong interpersonal skills

About the Department

The Biotech & Rare Disease Quality Assurance Finished Products Kalundborg department is a rapidly developing team responsible for QA for Biotech & Rare Disease packaging, producing haemophilia products and glucagon.

About Novo Nordisk

Novo Nordisk is a global workplace where passion and engagement are met with opportunities for professional and personal development. We offer a chance to be part of a truly global workplace, where you can make a difference in the lives of millions of patients living with diabetes and other chronic diseases.



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