Quality Assurance (Supply Chain)

Quality Assurance is ensuring quality standards are achieved and maintained at suppliers through supporting management, and gives oversight on Quality Operations functions for external business partners. This support includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), audit activities, pro-active Quality Engagement, creation and management of risk mitigation plans for suppliers. Main Duties • Support of planning, execution, and documentation of the qualification and monitoring of suppliers who are sourcing API materials and Drug Product materials to the Supply Chain for the manufacture of API Intermediates, APIs, Excipients and Packaging Materials for the manufacture of Drug Products respectively. • Surveillance on the quality and compliance status for all third party supplied raw materials, intermediates, APIs, Excipients, and Packaging Materials. • Provision of all information needed for the release/reject of suppliers in SAP (SAP master data) • Support establishment and periodic review of Quality Agreements • Support establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers • Execution of monitoring and trending reports for suppliers. • Provides support to EQ Supplier Quality representative and subject matter expert during regular audits and health authority inspections • Coordinate Supplier Specification Agreements and approval management ...... Your profile • You are fluent in English and Dutch • You have a master's degree • You love working on projects and like varying tasks and environments