19 Aug
|
Cadila Pharmaceuticals
|
Dholka
19 Aug
Cadila Pharmaceuticals
Dholka
"• 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 current 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 implementati
📌 Senior Executive (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka