Review and co-approve Quality Technical Agreements with GMP vendors, and ensure any project study changes in scope are appropriately reflected
Manage GMP documents, review and co-approve batch records, and ensure proper control and archiving of quality-related data
Work closely with Regulatory Affairs to ensure that all manufacturing and clinical activities remain in strict alignment with current regulatory filings (e.g., IND, CTA, or MAA) and to support the preparation of regulatory submissions
Product Release: Approve or reject raw materials, intermediates, and finished products, often involving data review and certification. Verify that batch documentation and product specifications comply with the 'Approved' versions filed with Health Authorities before final certification or release
Investigations: Investigate out-of-specification (OOS) results, deviations, and trends, performing root cause analysis (RCA)