GMP Compliance Specialist

1 week ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time
Job Summary
The GMP Compliance Specialist plays a critical role in ensuring that the Chemistry Pilot Plant at Novo Nordisk PSQIT organization meets all regulatory requirements. This includes driving quality-related tasks and projects across the department, coordinating and implementing cross-functional quality projects, and setting quality goals for the department. The ideal candidate has a strong background in science, specifically in GMP from a production environment, and a minimum of 3-5 years of experience working within a regulated area. Fluency in English is essential, both written and spoken. A key aspect of this role is the ability to work independently and as part of a team, demonstrating initiative, curiosity, and a willingness to strive for process simplification. Additionally, the candidate should be familiar with the LEAN way of working and possess excellent communication skills.

About the Team
You will be joining the Chemistry Pilot Plant team at Novo Nordisk PSQIT organization, which is dedicated to developing, manufacturing, and distributing drug candidates for clinical trials. This team operates within a strong culture of collaboration, innovation, and a 'can do' mind-set, driven by a commitment to making a real difference for patients with chronic diseases worldwide.

Key Responsibilities
The main responsibilities of the GMP Compliance Specialist include:
  • Driving quality-related tasks and projects across the department.
  • Coordinating and implementing cross-functional quality projects where you will be the department's go-to person.
  • Setting quality goals for the department and ensuring that the quality system is compliant with regulatory requirements.

Requirements
To be successful in this role, you should have:

  1. A bachelor's degree in Engineering, Chemistry, Pharmacy, or another relevant field.
  2. At least 3-5 years of experience from working within a GMP regulated area.
  3. Experience with the LEAN way of working/mind-set.
  4. Fluency in English, both written and spoken.


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