QA Manufacturing Floor Scientist - cGMP & Compliance

AGC Biologics; Søborg; On-site; DKK 480,000 - 600,000; Full time

Job summary

AGC Biologics, a global CDMO, is hiring a QA Manufacturing Support Scientist at our Søborg site in the Copenhagen area. You will provide extensive quality oversight on the production floor, review Line Approvals and Master Production Records, and manage deviations, CAPAs, and change requests in a cGMP environment.

You will participate in audits, drive continuous quality improvements, and be on-call for on-line support during critical process steps—approximately one weekend per month.

Qualifications

• MSc in Natural Science or Life Science is required.
• Experience in a cGMP environment is highly valued.

Responsibilities

• Provide extensive quality oversight on the production floor.
• Handle Line Approval, and review/approve Master Production Records (MPR) and label management for production use.
• Manage DEVs, CAPAs, and Change Requests (CRs).
• Support audits and inspections and drive continuous quality improvements.
• Be on-call on weekends (approx. 1 per month).

Education

MSc in Natural Science or Life Science

Job description

AGC Biologics, a global CDMO, is hiring a QA Manufacturing Support Scientist at our Søborg site in the Copenhagen area. You will provide extensive quality oversight on the production floor, review Line Approvals and Master Production Records, and manage deviations, CAPAs, and change requests in a cGMP environment.

You will participate in audits, drive continuous quality improvements, and be on-call for on-line support during critical process steps—approximately one weekend per month.