QA IT Principal Scientist – Validation & Systems

AGC Biologics A/S; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

AGC Biologics A/S in Søborg is seeking a QA Principal Scientist with IT flair to lead QA for Facility, Utility, Equipment and IT assets, collaborating with IT, Engineering and Project Management.

The role combines QA oversight with IT validation, including CAPA, deviations, change control, and CSV. Requires a Masters in Pharmacy, Biotechnology, Biology, Engineering or IT with 8+ years in regulated manufacturing; English proficiency is essential.

Qualifications

• Master's degree in a relevant field plus 8+ years in regulated manufacturing environments.
• Strong QA background with experience in deviation handling, CAPA and Change Control.
• Knowledge of Computer Systems Validation (CSV) and IT/OT compliance.

Responsibilities

• Provide QA support for complex Deviations (DEV), CAPAs, and Change Requests (CRs).
• Oversee IT Systems, Automation, and Data Integrity to ensure GMP compliance.
• Lead improvements to quality processes and document review/approval of qualification documents.
• Engage in Trend Report analysis for quality activities related to Facility, Utilities, and Equipment.
• Collaborate with IT, Engineering and Project Management across departments.

Skills

QA oversight

Deviation handling

CAPA

Change Control

Qualification documentation review

CSV - Computer Systems Validation

IT/OT compliance

BI and dashboards

Education

Master's degree in Pharmacy, Biotechnology, Biology, Engineering, IT

Tools

SOPs management

Job description

AGC Biologics A/S in Søborg is seeking a QA Principal Scientist with IT flair to lead QA for Facility, Utility, Equipment and IT assets, collaborating with IT, Engineering and Project Management.

The role combines QA oversight with IT validation, including CAPA, deviations, change control, and CSV. Requires a Masters in Pharmacy, Biotechnology, Biology, Engineering or IT with 8+ years in regulated manufacturing; English proficiency is essential.