Manage or oversees & coordinates the Validation i.e. Validation of manufacturing processes, cleaning procedures, Lab & production equipment, engineering facilities, utilities, production control systems & Computer systems at Site & ensuring that all the elements of validation life-cycle approach i.
e. Planning & Requirements, Design, Testing, Reporting, Use & Decommissioning Phases are in place & in use. Prepare validation weekly & monthly plan to prioritize work.
Coordinates the various validation activities with production and QA personnel. Create & maintain effective validation tracker to supervise & govern site validation activities.
Develops, prepares, review and approved validation documentation for departments & projects (Master Plans, Protocols, and SOPs) as per current company policies & regulatory guidelines.
Participate inter-GSK site & GSK functions project and activities. Develops, prepares and acts on Validation Master Plans for departments and projects.
Liaises with departments w.r.t validation status / requirements.
Assists with NPI w.r.t manufacturing processes applies knowledge & experience.
Responsible for governing system validation status by review and approve site validation review plans.