GMP Compliance Expert

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About This Role:

This position is part of the Quality Assurance department, which consists of over 80 colleagues with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment.

Main Objective:

The main objective of the team is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines at all times.

Responsibilities:

The GMP Compliance Expert will be responsible for overseeing the Quality Assurance review and approval of all technical documents.

  • Document Review:
  • Review and approve documentation related to change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, qualification protocols, and reports.


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