Intern - GMP Quality Assurance

Summary

The Intern will be part of the Commercial Manufacturing QA team responsible for the Quality oversight of commercial manufacturing activities associated with Drug substances, Drug Products and primary and secondary packaged Products.

Duties And Responsibilities

• Implement Quality & Technical Agreements (QTA) templates for Commercial Manufacturing activities matching.
• Coordinate the collection of CMOs Annual Product Quality Review (APQR) reports and support the issuance of Incyte APQR Reports.
• Support vendor management activities such as update of Veeva Organizations and collection of vendor statements.
• Review and harmonize classification of QA related documents in eDMS.
• Support the collection of SM vendor batch documentation to prepare Incyte batch disposition.
• Support the management and monitoring of Supplier Change Notification (SCN).
• Support the management and monitoring of inte...

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