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 Positive 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."""

📌 Senior Executive (India)
🏢 Cadila Pharmaceuticals
📍 India