"• 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 recent 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 implementati