Senior Quality Assurance Specialist – GMP Manufacturing (12‑month contract)

About the role

We are seeking an experienced Senior Quality Assurance Specialist to support GMP manufacturing and biopharmaceutical process development on a 12‑month contract. You will work closely with Manufacturing, Quality Control, MSAT, Procurement and Supply Chain teams to ensure compliance and drive continuous improvement.

Key responsibilities

• Provide real‑time QA support during GMP manufacturing, laboratory and process development activities.
• Review batch and manufacturing documentation for GMP compliance.
• Approve and oversee QMS records, including Deviations, CAPAs, Change Controls and Investigations.
• Escalate and manage major GMP compliance issues.
• Maintain inspection and audit readiness.
• Mentor colleagues on cGMP principles and quality best practices.
• Lead continuous‑improvement initiatives across quality systems.
• Represent QA in cross‑functional project and governance meetings.

Required profile

• Bachelor’s degree in Life Sciences or a related scientific discipline.
• Proven QA experience in the pharmaceutical, biotechnology or CDMO sector.
• Strong knowledge of EU GMP regulations and Quality Management Systems.
• Hands‑on experience reviewing batch documentation and managing Deviations, CAPAs, Change Controls and Investigations.
• Excellent communication and stakeholder‑management skills.
• Ability to work effectively in cross‑functional, GMP‑regulated teams.

Required skills

• EU GMP regulations
• cGMP principles
• Quality Management System (QMS)
• Deviations handling
• CAPA management
• Change Control processes
• Investigation documentation
• Lean/continuous‑improvement methodologies

What we offer

• 12‑month contract with possible extension.
• Competitive hourly or daily rate.
• Opportunity to work with a leading life‑sciences organisation on high‑impact GMP projects.
• Collaborative, international environment.
• Immediate or short‑notice start preferred.