Senior Officer
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Job Description
Major purpose of the job:• Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Udaipur site in line with the cGMP requirements of national and international regulatory authorities.
• To Perform Vendor Management Activity to assure that Vendors Are Complying with CPL SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products. Principal Task and
Responsibilities:
1. To perform the validation exercises of new as well as existing equipment’s, utilities and critical systems. 2. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports. 3. Preparation of SOPs pertaining to qualification and Validation activities. 4. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks. 5. To prepare, review, execute and compile the protocol and report of Transportation Validation. 6. Coordination with cross functional teams for smooth conduction of validation activities with respect to: ? Equipment Qualification / Re-Qualification, Validation / Re-Validation ? HVAC System Validation and Utility Validation ? Temperature Mapping Study of critical area 7. To initiate and review change control, deviation and CAPA 8. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies 9. Responsible to assist for handing of activities related to Vendor Approval. 10. To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM. 11. To assist for preparation of Approve Vendor List of RM/PM and to assist for preparing Vendor Grading of RM/PM based on Rejection of Supply from Vendors on Yearly Basis. Any other jobs assigned from time to time.
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