Review the investigations related to TPO that are received from various CMO/Suppliers related to Deviations including manufacturing, laboratory, etc. OOS & OOT related to commercial batch releases. Maintain the KPI metrics related to Investigations.
Check for the adequacy of the investigations & coordinate with the CMO, internal stake holders to get the Complete / Compliant investigation through QRM's. Knowledge & working experience with USFDA / EU and other competent authority approved sites.