Profile summary:

10 year experience in pharmaceutical sector experience in (Lyo injectable, liquid injectable, PFS and terminally sterilized product and Dry syrup formulation.) Responsible as manager in section Quality operation and Quality management system. Skill in handling investigation, RCA, Market complain, OOS, OOT, OOAC and OOAL. Handling Deviation,CAPA,Change control, All QMS related activity. Expertise in validation of autoclave, Freeze dryer,tunnel, vial washing machine, Terminal sterilizer, Filling machine and filling Isolator. Perform area and equipment and utility qualification, Temperature distribution study Handling project for qualification of new aseptic injectable facility expansion. Involved in site transfer of parenteral formulation. Perform process validation, media fill validation and cleaning validation. Audit faced US FDA, MHRA, TGA and ANVISA etc..