Quality Assurance Specialist

6 days ago

Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities

  • Review and approve batch documentation related to Environmental Monitoring, and review and approve supporting processes, trend reports, Standard Operating Procedures (SOPs) and deviations.
  • Perform QA oversight, observing performance of processes and helping solve issues in real time.
  • Advise stakeholders to ensure the right level of quality in the production processes.
  • Participate and present cases when we are inspected by authorities from around the world.
  • Improve processes in your working area.

Requirements

  • A master's degree in pharmacy, medicine, microbiology, veterinary medicine or similar.
  • 1 year of experience within QA or other relevant production related job would be advantageous.
  • Knowledge of Good Manufacturing Practice (GMP) and regulations.
  • Strong communication skills with stakeholders, maintaining a respectful tone.
  • Proficiency in English (both oral and written), along with good IT skills.

About the Department

The Aseptic Manufacturing QA department at Novo Nordisk A/S is a well-functioning team with many interfaces in the organization including production, management, and other QA departments. We are a team of 60 engaged employees with a great team spirit, and we overcome obstacles with open and honest communication. We love professional challenges, working with individual responsibilities, and this is one of the best places to work and develop.

Our Mission

Our main task is to help set and ensure the quality direction of our production area, thereby having direct impact on products delivered to patients all over the world. Meaning, our QA role is to advise and confirm to ensure our production is in compliance with internal and external guidelines at all times.

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