QA Specialist – Commissioning

Ensuring high-level compliance and robust qualification processes is critical to delivering safe, reliable therapies and healthcare solutions.

We are currently recruiting a QA Specialist - C&Q to act as a key quality partner across system lifecycle and qualification projects.

Your role:

• Lifecycle & Qualification Oversight: Review and approve critical qualification packages, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, and summary reports.
• Compliance & Procedures: Review and approve procedures tied to system qualification, calibration, maintenance, and lifecycle management.
• Quality Investigations: Assess and thoroughly investigate deviations related to system qualification, maintenance, or usage, defining effective CAPAs.
• Audit Readiness: Serve as a subject matter expert for C&Q topics during internal audits, client visits, and regulatory inspections.
• Cross-Functional Collaboration: Challenge constructively and work closely with engineering, validation, and operations teams to meet project deadlines.

What we are looking for:

• Medior QA profile with hands-on experience in a strictly regulated environment (Pharma/Biotech).
• Solid background in qualification (C&Q / CQV) deliverables and QA methodologies.
• Rigorous compliance mindset paired with constructive communication skills.
• Ability to manage multiple priorities and maintain strong relationships with stakeholders.

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