QA IT Principal Scientist — GMP Systems & Validation

agcbio; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

AGC Biologics in Søborg seeks a QA Principal Scientist with IT flair to lead QA for Facility & Equipment and support IT/OT compliance. You will collaborate across IT, Engineering and Project Management, coaching colleagues and stakeholders while driving quality throughout GMP manufacturing.

The role emphasizes QA oversight, deviations, CAPA and Change Control, with a focus on validation, data integrity, and continuous improvement in a dynamic, global CDMO setting.

Qualifications

• Masters in Pharmacy or related field.
• 8+ years in regulated manufacturing environments.
• Experience in CDMO environment and QA oversight.

Responsibilities

• Review and approve SOPs and qualification documents (Qualification/validation protocol and report, URS, VPL, RTM, TEQ, CIL).
• Provide QA support on Deviations (DEV), CAPAs and Change Requests (CRs).
• Oversee IT Systems, Automation and Data Integrity to ensure GMP compliance.
• Lead improvement initiatives to increase efficiency of Quality processes.
• Review and approve system and equipment related quality documentation.
• Handle QA activities for facilities, utilities, equipment and computerized systems.
• Support Computerized Systems Validation (CSV) and trend analysis for quality activities.

Skills

QA

IT validation

GMP compliance

CAPA

Change control

Document review

CSV

BI dashboards

Education

Master's degree in Pharmacy

Job description

AGC Biologics in Søborg seeks a QA Principal Scientist with IT flair to lead QA for Facility & Equipment and support IT/OT compliance. You will collaborate across IT, Engineering and Project Management, coaching colleagues and stakeholders while driving quality throughout GMP manufacturing.

The role emphasizes QA oversight, deviations, CAPA and Change Control, with a focus on validation, data integrity, and continuous improvement in a dynamic, global CDMO setting.