Senior/Principal Scientist, Quality Control

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Unlock Your Expertise in Quality Control

About the Role

We are seeking a highly skilled Senior/Principal Scientist, Quality Control to join our dynamic and international team at AGC Biologics. As a key member of our QC Raw Material team, you will play a crucial role in implementing new raw materials to support new phase I/II projects, planning the Raw Material Qualification and Release Testing program for late stage projects, and ensuring compliance with European or US regulatory guidelines.

Key Responsibilities

  • Develop and review raw material specifications based on regulatory guidelines and adapt to supplier change notifications.
  • Deliver scientifically sound and cGMP compliant raw material documents and analytical results.
  • Contribute to the operation of the raw material program, including risk assessments and creating qualification protocols/reports.
  • Oversight of sampling, both internal and outsourced testing.

Requirements

  • MSc or PhD degree in Chemistry, Pharmaceutical Sciences, or a relevant area.
  • Experience in quality control or quality assurance, preferably with work experience in a similar role.
  • Profound writing and reviewing skills of cGMP documents, including raw material specifications, test methods, and general procedures.
  • Experience setting specifications for compendial and non-compendial raw materials.
  • In-depth understanding of US and European pharmacopoeias.
  • Experience handling change controls, deviations, and CAPAs, including root cause investigation and laboratory investigations.
  • Ability to work independently and as part of a team, with excellent communication and problem-solving skills.

Location

Copenhagen Site



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