Quality Assurance Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a skilled Quality Assurance Specialist to join our team in Emerging Technologies API Manufacturing Development (ET API MDev). As a key member of our organization, you will play a crucial role in ensuring compliance with GxP guidelines and regulations.

Key Responsibilities

  • Act as a one-point-of-entry for audits and inspections, driving planning and execution while ensuring overall inspection readiness.
  • Support and drive the yearly planning of quality activities across the department, strengthening and maintaining the training setup in collaboration with department specialists.
  • Be the go-to person on quality subjects, actively identifying and driving quality improvement projects using systematic problem-solving and Lean methodologies.

Requirements

  • An academic degree in a relevant field, such as Pharmacy, Engineering, or Science, or equivalent knowledge through relevant practical experience.
  • Minimum 2 years' experience within GxP guidelines and regulations, with current legislation expertise.
  • Proficiency in both spoken and written English.

About Our Department

As part of Novo Nordisk's Product Supply organization, you will work at the interface between CMC and full-scale manufacturing, focusing on process understanding, implementation, optimization, and life cycle management. You will have the opportunity to collaborate with other highly qualified and motivated colleagues in a multidisciplinary project environment.



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