About this role
The Qualified Person is responsible for batch release, ensuring product quality and compliance with applicable regulatory requirements, including cGMP, Dutch legislation, and relevant European pharmaceutical regulations. This role provides quality oversight of operational activities and ensures the effective implementation, monitoring, and maintenance of a GMP-compliant quality system. The Qualified Person is also responsible for supporting a reliable supply chain through the timely release of radiopharmaceutical products. Key responsibilities include the review and release of batch analysis in accordance with applicable requirements, the relevant Marketing Authorisation, and European Union pharmaceutical legislation, including Directive 2001/83/EC for medicinal products for human use.
About the Role Major accountabilities
Responsible for the timely release of radiopharmaceutical products manufactured on site, partnering with Supply Chain to support reliable product supply. Release batch analysis in compliance with applicable requirements, including EU Directive 1/83/EC and relevant national pharmaceutical regulations. Provide quality, compliance, and technical expertise to ensure deviations, CAPAs, and related quality activities.