Handling of Quality management system like Market complaints, Change Control, Deviations, OOS, OOT, Incidents, CAPA, Self-Inspection, Vendor Qualification.
Review and Approval BMR/BPRs, Prepare of Standard Operation Procedure, Process Validation, Hold Time Study Protocol and Reports, Annual Product Quality Review & trending, Cleaning validation.
Qualification/ requalification of Equipments.
Release of Finished Product, Continuous Process Verification, Trainings etc.