Define and plan validation activities to meet the cGMP requirements, coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and/or software; analyze validation related issues, implement validation related event, Change Control and CAPA.

Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Department of Health and respond to their queries, provide regulatory support to internal departments.

Sampling and testing of raw materials, packaging materials, purified water, in-process samples, finished products and stability studies samples, operation of laboratory equipment, assisting in laboratory equipment calibration, qualification and maintenance.