QA IT Principal Scientist: GMP, Equipment & Data Integrity

AGC Biologics; København; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

AGC Biologics in Søborg Denmark seeks a QA Principal Scientist with IT flair to support and lead QA IT validation for facility, utility, equipment, and IT assets. The role partners with IT, Engineering, and Project Management to improve quality systems and drive continuous improvement.

The ideal candidate holds a Master’s degree in life sciences or IT with 8+ years in regulated manufacturing, strong QA background, and experience in CSV, CAPA, and Change Control.

Qualifications

• 8+ years in regulated manufacturing environments.
• Strong QA background with emphasis on IT validation.
• Experience with Computer Systems Validation (CSV) and GMP compliance.

Responsibilities

• 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 in QA processes.
• Review and approve system and equipment related quality documentation.
• Engage in trend report analysis for quality activities related to facilities and equipment.

Skills

QA IT

CSV

GMP

CAPA

Change Control

IT Systems

Education

Master's degree in life sciences

Tools

BI dashboards

Validation tools

Job description

AGC Biologics in Søborg Denmark seeks a QA Principal Scientist with IT flair to support and lead QA IT validation for facility, utility, equipment, and IT assets. The role partners with IT, Engineering, and Project Management to improve quality systems and drive continuous improvement.

The ideal candidate holds a Master’s degree in life sciences or IT with 8+ years in regulated manufacturing, strong QA background, and experience in CSV, CAPA, and Change Control.