▪ Prepare Quality Manual, Quality Procedure, Site Master File, SHE Manual, SOP, Forms and other quality documents.▪ Prepare Validation Master Plan and execute all validation activities according to the plan.▪ Perform All Validation & Qualification including HVAC System, Water System.▪ Monitor & record Out of Spec, Change Control, Deviation, CAPA, and Risk Assessment.▪ Prepare Product Quality Review & Trend Analysis.▪ Successfully satisfied Drug auditors more than 8 times, International Audit from Kenya and Vietnam. Conduct Self Inspection twice a year.▪ Prepare Annual Training plan to execute to maintain cGMP practice.Sophisticated Machine Performance▪ Operation & Maintain UV- Vis Spectrophotometer (Shimadzu, Japan)▪ Operation & Maintain FTIR Spectroscopy ((Shimadzu, Japan)

▪ Prepare SOP, Quality System Procedure, Validation Plan, Protocol and others other quality documents. ▪ Prepare Annual Training plan for Management and execute to maintain cGMP practice.▪ Prepare Product Quality review report, Change Control, Deviation Report▪ Investigate and handling Customer Complain, CAPA Report.

▪ Trend analysis & evaluation of deviation report, Master file compilation▪ Conducting Validation process & procedure as a team member▪ Carry out the in-process, compilation Batch Documents, Master File compilation