About this role
Hays Save QA Specialist HAYS|QA|Deviations|Documentation|GMP|CAPA|CQV|Quality Systems| 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 su...