GCS Document Specialist

Packaging Specifications (PS), Certificate of Compliance/Conformance (CoC), Certificate of Analysis

(CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release

Certificates, Global Distribution Specifications (GDS), Drug Return Instructions (DRI), Certificate of Destruction (CoD) IRT:

IRT specifications (Endpoint PULSE and Almac IXRS), Endpoint DRIVE Specifications, User Acceptance

Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate

• Audit trail report requests for site/user changes for audits and inspections