Quality Assurance Manager

Job Responsibilities

• 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.