QA Consultant – Drug Product Manufacturing

About the role

We are seeking an experienced QA Consultant to join a leading international biopharmaceutical manufacturing organisation in Hillerød. The role is focused on supporting sterile drug product manufacturing operations, ensuring high‑quality documentation and compliance with GMP standards.

Key responsibilities

• Manage and review deviations and CAPAs within drug product manufacturing.
• Partner with subject‑matter experts to conduct robust investigations and implement corrective actions.
• Review and support change controls, ensuring alignment with quality and regulatory requirements.
• Participate in project kick‑off meetings and cross‑functional discussions related to quality events.
• Review and approve work orders for maintenance and equipment activities.
• Support risk assessments and quality documentation across the facility.
• Collaborate with operational teams to maintain inspection readiness and GMP compliance.

Required profile

• Minimum 5 years of Quality Assurance experience in the pharmaceutical industry.
• Strong background supporting drug product manufacturing operations.
• Experience managing quality records such as deviations, CAPAs, change controls and risk assessments.
• Knowledge of sterile manufacturing and Annex 1 requirements.
• BSc or MSc in Pharmacy, Life Sciences or a related scientific discipline.
• Detail‑oriented, strong communicator and effective team player.

Required skills

• GMP expertise
• Sterile manufacturing
• Annex 1 compliance
• Deviation management
• CAPA management
• Change control
• Risk assessment