Scientist, Quality Assurance Specialist

2 months ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Key Responsibilities
  • Author and review raw material specifications based on European or US regulatory guidelines.
  • Deliver scientifically sound and cGMP compliant raw material documents and analytical results.
  • Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports.
  • Oversight of sampling, as well internal as outsourced testing.

Requirements
• 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.
• An experienced multi-tasker and you enjoy working in a high pace and being challenged in a busy business.

About Us
Join a dynamic and international company where everyone is responsible for delivering right on time as one team.



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