Senior Executive
Job Description
"• To ensure compliance of Validation, Qualification, Re-Qualification and Re-Validation activities as per schedule pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• Planning and execution of Process Validation, Packing Validation, Transportation Validation and Cleaning Validation activities pertaining to Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• To prepare, review and approve SOP’s., Validation & Qualification protocols and reports.
• To perform the validation exercises of new as well as existing equipment’s, utilities and critical systems.
• 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 - Process Validation of new product as well as existing products - Hold Time Study - Packing Validation, Transportation Validation of products - Cleaning Validation
• Coordinate and participate in Aseptic Process Simulation (Media fill) Studies.
• To review and approve CAPA, Deviation & Change Control.
• To ensure smooth technology transfer of new product to plant level sign the Technical agreement with customer.
• To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks.
• To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all such international quality standards.
• To ensure that the product meets the defined standards for strength, identity, safety, purity and quality by various system-driven approaches.
• To appoint the qualified staff for technical function and ensuring their technical and overall development through systematic training processes and reviewing their performance periodically.
• Ensure proper implementation of corporate policies / guidelines.
• To participate various regulatory / customer audits and ensure the compliances of Audit observation.
• To ensure cGMP related training program for all concerned manpower.
• Responsible to assist for handing of activities related to Vendor Approval.
• To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM.
• To prepare, review, execute and compile the protocol and report of Process Validation.
• To prepare, review, execute and compile the protocol and report of Hold Time Study.
• To prepare, review, execute and compile the protocol and report of Packing Validation.
• To prepare, review, execute and compile the protocol and report of Transportation Validation.
• To prepare, review, execute and compile the protocol and report of Cleaning Validation.
• Any other jobs assigned from time to time."""