To Prepare, manage and review validation master plan and cleaning validation master plan. To prepare and summarize results when writing final validation. To review and coordinate for all type of third party calibration. To prepare execute protocols and report of process validation, hold time study, HVAC, Water system and collection of samples. To initiate and evaluate of change control, risk assessment of product as well as equipment. To prepare annual product review and provide data related to validation and qualification. To follow and implement current GDP and SOP during work.