09 Oct
|
Cadila Pharmaceuticals
|
Dholka
09 Oct
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 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 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 implementati
📌 Senior Executive Dholka
🏢 Cadila Pharmaceuticals
📍 Dholka