GMP Compliance Specialist

3 weeks ago


Gentofte, Gentofte Kommune, Denmark Novo Nordisk Full time

About the Role

We are seeking a highly motivated and experienced GMP Compliance Specialist to join our team at Novo Nordisk. As a GMP Compliance Specialist, you will play a key role in upholding and enhancing a high level of Good Manufacturing Practice (GMP) within our organization.

Key Responsibilities

  • Drive the preparation for and oversee the follow-up on authority inspections and internal audits
  • Coach and assist colleagues in GMP-related tasks such as deviations, changes, and projects
  • Prepare and/or approve trend reports, Quality Oversight Tools, and Quality Management Review (QMR)
  • Maintain a high-level GMP overview and report on GMP and quality trends to management

Requirements

  • Academic degree in pharmacy, biology, engineering, or a similar field
  • At least 4 years of experience in the pharmaceutical or medical device industry, with a focus on GMP regulated areas and complex production processes
  • Ability to think and act with a broad perspective, encompassing the big picture while maintaining focus on crucial details
  • LEAN mindset with experience in systematic problem solving
  • Professional proficiency in English

About the Department

You will join the PS AM Gentofte HAC Aseptic Filling L6 department, a filling department currently in the project phase. We are an isolator filling line focusing on and preparing for handover to start production after the summer next year.

Working at Novo Nordisk

At Novo Nordisk, we drive change and strive for excellence without fixating on perfection. We're a dynamic company in a dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.



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