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GMP Coordinator

2 months ago

Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly skilled GMP Coordinator to join our team at Novo Nordisk A/S. As a GMP Coordinator, you will play a critical role in ensuring the highest standards of compliance and quality in our packaging department.

Key Responsibilities

  • Drive the preparation and oversight of authority inspections and internal audits.
  • Coach and assist colleagues in GMP-related tasks, such as deviations, changes, and projects.
  • Prepare trend reports, Quality Oversight Tools, and Quality Management Reviews (QMR).
  • Maintain a high-level GMP overview and report on GMP and quality trends to management.
  • Lead projects to success and drive business growth.

About the Department

We are a part of Finished Production Manufacturing DK-2, a team of approximately 100 people working together to ensure the highest standards of quality in our finished products. We bring value to our patients by delivering high-quality products in accordance with Good Manufacturing Practice (GMP) in a timely and cost-effective way.

Requirements

  • Bachelor's or Master's degree in pharmacy, biology, engineering, or a related field.
  • Minimum four years of experience in process support, packaging, or QA in the pharmaceutical, medical device, or similar regulated industry.
  • Strong experience and skills in GMP-regulated environments and complex production processes.
  • Ability to see the big picture while maintaining attention to detail.
  • Fluency in both Danish and English, allowing seamless communication across the organization.