Qualified Person

Job description

Job Description Summary Ensuring the quality of products and compliance with regulatory requirements and cGMP. Responsible for the quality oversight for the operational activities, assurance of compliance to the Dutch Law and other applicable regulations and maintaining and effective implementation, monitoring, and maintenance of a GMP-compliant system. Responsible for the timely release of the radiopharmaceutical products to ensure a reliable supply chain. Release of batch analysis in accordance with the relevant requirements and the European Union pharmaceutical regulation (Directive 2001/83/EC for medicinal products for human use) in line with the market authorisation. Job Description: Major Accountabilities: Responsible for the release of the radiopharmaceutical products manufactured on site. Partner with Supply Chain to ensure timely release in support of a reliable supply chain. Release of batch analysis in accordance with the relevant requirements and the European Union pharmaceutical regulation Directive 2001/83/EC for medicinal products for human use and the National law. Ensure that deviations, CAPAs, Change Controls and Product Quality Complaints are timely and properly...