Your new role

The QA Specialist is responsible for providing Quality Assurance support to a large-scale Commissioning & Qualification (C&Q) programme within a GMP-regulated pharmaceutical environment. In this role, you will ensure quality oversight of C&Q activities, documentation, and records, supporting the successful transition of facilities and systems into GMP operations. Working closely with the Project QA Lead and cross-functional project teams, you will help drive GMP readiness and ensure compliance throughout the project life cycle.
Key Responsibilities:

• Review and approve quality-impacting C&Q documentation, protocols, reports, and records.
• Provide QA oversight for commissioning, qualification, and validation activities.
• Support deviation investigations, change controls, and CAPA activities arising during the C&Q programme.
• Perform vendor quality reviews and documentation quality checks to ensure compliance with GMP requirements.
• Support data integrity expectations by verifying the accuracy, completeness, and traceability of project documentation.
• Collaborate with Engineering, CQV, Manufacturing, and Quality teams to resolve compliance-related issues.
• Support GMP readiness assessments and handover preparation activities for systems and facilities.
• Ensure project deliverables comply with internal quality standards and applicable regulatory requirements.
• Contribute to continuous improvement initiatives that strengthen quality systems and project execution.

What you'll need to succeed

You have a minimum of 5 years of experience within Pharmaceutical Quality Assurance and a strong understanding of GMP regulations. Experience reviewing Commissioning & Qualification documentation is essential. You have working knowledge of deviations, change controls, CAPA processes, and GMP facility start-up activities. Experience supporting large capital projects, facility expansions, or equipment qualification programmes is highly desirable. You are detail-oriented, proactive, and comfortable working with multiple stakeholders in a project-based environment. Strong communication skills in English are required.

What you'll get in return

Hays Detachering | This is a long-term project opportunity based on-site in Leiden. You will initially join through Hays with the possibility of extension depending on project requirements. In return, you will receive a competitive salary package, travel expense reimbursement, and the opportunity to contribute to a high-profile pharmaceutical start-up and GMP readiness programme.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

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