via Career pages·Yesterday
Senior Executive
Cadila Pharmaceuticals
Full-timeOn-sitevalidationcgmpprocess validation
Location:Dholka, IndiaType:Full-timePosted:Yesterday
- 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.
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