QA IT & Facilities Scientist — GMP Compliance

AGC Biologics; København; On-site; DKK 1,000,000 - 1,500,000; Full time

Job summary

AGC Biologics in Søborg seeks a QA Principal Scientist with IT flair to oversee QA for facility, utility, equipment and IT assets. You will validate systems, review qualifications, and drive CAPA/CR processes in a fast-paced GMP environment.

The role emphasizes collaboration with IT, Engineering and Project Management, with coaching responsibilities for colleagues and stakeholders across the business. English proficiency is required.

Qualifications

• Masters degree in a relevant field and 8+ years in regulated manufacturing.
• Experience with GMP requirements and QA oversight.
• Familiarity with CDMO environments is advantageous.
• Solid QA background in deviation handling, CAPA and change control.
• Experience reviewing qualification documentation.

Responsibilities

• Provide QA oversight for IT/OT systems and GMP facilities.
• Review SOPs, qualification documents, and validation reports.
• Support Deviations (DEV), CAPAs, Change Requests (CRs).
• Lead IT/QA validation activities and data integrity initiatives.
• Collaborate with IT, Engineering and Project Management across sites.

Skills

QA oversight

Deviation handling

CAPA

Change control

GMP compliance

Data integrity

IT validation

Stakeholder management

Problem solving

Biotech QA

Education

Master's in Pharmacy

Master's in Biotechnology

Master's in Engineering/IT

Tools

BI dashboards

CSV

Job description

AGC Biologics in Søborg seeks a QA Principal Scientist with IT flair to oversee QA for facility, utility, equipment and IT assets. You will validate systems, review qualifications, and drive CAPA/CR processes in a fast-paced GMP environment.

The role emphasizes collaboration with IT, Engineering and Project Management, with coaching responsibilities for colleagues and stakeholders across the business. English proficiency is required.