PURPOSE

Lead the end to end implementation of a Serialization Level 5 system to support US DSCSA reporting, ensuring full compliance with Computerized system Validation ( CSV) requirements per GAMP 5 / 21 CFR Part 11 / EU Annex 11. The role bridges Digital Technology (DT), Operations, Quality and external vendors to deliver a validated, production ready system on time and within budget.

Key responsibilities

Execution Lead:

• Define and maintain DT project execution plan, milestones, budget and RAID log for the L5 serialization deployment for US DSCSA regulation....