Support of planning, execution, and documentation of the qualification and monitoring of suppliers who are sourcing API materials and Drug Product materials to the Janssen 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.
- Support Account Owners on initial assessment and qualification of suppliers for new product introductions
- Support of change management, deviations, escalations, compliance issues, recalls, field actions that are related to suppliers
- 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
- Keep AIM (Auditee Information Management) records updated with any information related to material, qualification and monitoring activities
Interested in this vacancy? Send your cover letter and CV to email@example.com or call +32 2 472 73 61