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Regulatory Compliance Coordinator

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About the Role

We are seeking a highly motivated and organized QC Coordinator/Analytical Project manager to join our QC Chemistry team. The successful candidate will be responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial.

Responsibilities:

  • Liaising with cross-functional teams to ensure timely delivery of analytical method validations
  • Maintaining knowledge and overview of QC Project milestones and Batch release schedules
  • Responsible for coordination and overall timeliness of analytic method validations in collaboration with QC Subject Matter Experts
  • Specification owner including establishment and update of Specifications
  • Keeping overview and driving the in-house transfer of analytical methods from Analytical Development to QC

What We Offer:

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.