Description
The role executes GMP batch disposition and release for active pharmaceutical ingredients and intermediates, reviewing batch records, certificates of analysis, and external CMO/CDMO documentation against approved specifications and the Quality Management System. It coordinates release-blocking deviations, OOS/OOT investigations, documentation gaps, and risk-based release decisions; maintains inspection-ready records in Veeva; tracks release cycle time and backlog; and partners with manufacturing, supply chain, regulatory, and other stakeholders to support supply continuity and continuous improvement.
