Senior QA Specialist for Regulatory Compliance

6 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a highly skilled and experienced QA Specialist to join our team in Clinical Trials. As a member of our Quality Assurance department, you will play a crucial role in ensuring the quality and safety of products for clinical trials.

In this dynamic environment, you will work closely with our team of experts to deliver best-in-class quality for qualification of equipment/facilities and IT-systems.

Key Responsibilities:

  1. Setting Quality Direction: Provide scientific leadership and direction on quality-related matters to ensure compliance with regulatory requirements.
  2. Qualification and Validation: Develop and implement robust qualification and validation plans to ensure that equipment, facilities, and IT systems meet regulatory requirements.
  3. Complex Problem-Solving: Collaborate with cross-functional teams to resolve complex quality issues and improve processes.
  4. LEAN Culture and Improvement: Drive a culture of continuous improvement and LEAN principles to optimize processes and reduce waste.

About Our Department

Our Quality Assurance department is responsible for ensuring the quality and compliance of our CMC API facilities & equipment and release of raw materials, cell banks, and API for clinical trials. We participate as QA for smaller or bigger investment projects to make our API Pilot facilities prepared for the future.

We value teamwork, diversity, and humor, and we will make sure that you feel welcome and included. A thorough individual training plan will be made for you together with your mentor.



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