To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies.
To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness.
To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date Approved Vendor List and requalification of Vendor Schedule.
To ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation.
Responsible for ensuring QMS elements (Change Control, Deviations, CAPA, OOS, OOT, etc.) are implemented and managed as per defined procedures.
To conduct Management Review Meetings and ensure follow-up on key quality metrics and action items.
To Represent the organization during customer audits and regulatory inspections; ensure timely responses and effective implementation of Corrective and Preventive Actions (CAPAS).
To Approve SOPs, Level-1 documents, and quality-critical documentation.
To ensure all critical and major changes (process, facility, or system) are executed based on risk assessment and maintain validated status post-implementation.
Authorized the Batches release in the Market.
To provide guidance to QA and cross functional departments for compliance to various international cGMP requirements. To co-ordinate with cross-functional HOD's to implement cGMP in Plant.
