Job Description

"1. Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities. 2. To Perform Vendor Management Activity to assure that Vendors are Complying with Cadila SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products. 3. To perform the validation exercises of new as well as existing equipment's, utilities and critical systems. 4. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports. 5. Preparation of SOPs pertaining to qualification and Validation activities. 6. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. 7. To prepare, review, execute and compile the protocol and report of Transportation Validation. 8. To Performed FAT(Factory Acceptance Test), SAT(Site Acceptance Test). 9. Coordination with cross functional teams for smooth conduction of validation activities with respect to: o Equipment Qualification / Re-Qualification, Validation / Re-Validation o HVAC System Validation and Utility Validation o Temperature Mapping Study of critical area 10. To initiate and review change control, deviation and CAPA 11. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies 12. Any other jobs assigned from time to time."