Job Description
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 inspe...
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