Research and Development Quality Control Expert

1 month ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Description

This is a dynamic role that involves implementing new raw materials for phase I/II projects, planning the Raw Material Qualification and Release Testing program, and ensuring compliance with regulatory guidelines.

Responsibilities
  • Develop and review raw material specifications based on European or US regulatory guidelines.
  • Create scientifically sound and cGMP compliant raw material documents and analytical results.
  • Involvement in operating the raw material program, including risk assessments and creating qualification protocols/reports.
  • Oversight of sampling, both internal and outsourced testing.
Requirements

The ideal candidate holds an MSc or PhD degree in Chemistry, Pharmaceutical Sciences, or other relevant area. Additionally, they should have experience within quality control or quality assurance, preferably in a contract manufacturing environment.

  • Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, 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.
  • A team player with the ability to work independently.
  • Experience representing the area in audits and inspections.
About AGC Biologics

We are a dynamic and international company where everyone works together as one team to deliver results on time.

Location

Copenhagen Site



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