QA Project Specialist

Hays Bewaar QA Project Specialist QA Project Specialist | Amsterdam | cGMP | Change Control | Validation | Pharmaceutical Manufacturing | 105035 QA Project Specialist Your new company Our client is an established biopharmaceutical organisation based in Amsterdam, specialising in the development and production of plasma-derived medicinal products. Their work focuses on transforming donated blood plasma into essential therapies used in areas such as immunology, critical care and rare disease treatment. With a strong scientific heritage and extensive experience in plasma fractionation and protein therapies, the organisation operates in a highly regulated cGMP environment where quality, patient safety and supply reliability are central to daily operations. Your new role As QA Project Specialist, you will provide Quality Assurance guidance across change control projects within a GMP-regulated production environment. You will act as the QA representative in multidisciplinary project teams and ensure that documentation, systems, processes and reports remain compliant with cGMP regulations, internal quality policies and external requirements. In this role, you will combine strong project coordination skills with in-depth QA knowledge, helping the organisation implement changes effectively while maintaining the highest quality and compliance standards. - Represent QA in change control projects within a GMP-regulated production environment. - Assess the quality impact, compliance risks and validation requirements of proposed changes. - Ensure change control documentation, reporting and system updates are accurate, complete and inspection-ready. - Translate quality strategies into practical guidelines, procedures and change control documentation. - Provide QA advice, training and guidance to internal stakeholders and project teams. - Act as Subject-Matter Expert during audits, inspections and quality-related stakeholder meetings. ...