India

Quality Management/Continuous Improvement:

Line clearance and shop floor compliance.
Review of logbook/log card of production area and Warehouse.
Participating in deviation investigations and change control management.
Ensure the implementation of CAPA wherever applicable and maintain appropriate documentation related to the same.
Coordination of cGMP training activity including training of the people.
Ensure proper line clearance during product-to-product change over.
Review of quality system SOP's


Compliance:

Ensure adherence to company Quality Standards, Local DFDA, MHRA & TGA regulations.
Understanding the requirements of GMP and data integrity aspects and ensuring its implementation.
Performing the gap analysis to find out the gaps in existing system
Preparing a compliance plan for closure of gaps
Execution of compliance plans in coordination with concerned Department
Prepare for and attend to external / regulatory Quality audits.


Validations & Qualifications:

Participate in development, approval & implementation of validation master plan.
Ensure validated status of all equipment, manufacturing processes and cleaning processes.
Review of validation / qualification plans for facility / utilities / equipment / instrument / process / computer / cleaning.
Review of protocols for qualification and validation of facility/equipment/ product/ process.
Review and certification of validation reports after execution of validation of facility /equipment / product / process