Naveen Kumar Jain

Senior Executive @Lupin Pharmaceuticals

Navi Mumbai, IN

Perform vendor audits for Key starting material, Excipient, Primary and secondary packing material.Track and review of compliance verification reports and closure of vendor audits.Co-ordination with site VQG for vendor qualification/vendor management related activities as a part of Vendor and Supplier life cycle management.Coordination with the vendors for audit planning and scheduling and ensuring timely execution of the planned (new/periodic) audits.Ensuring necessary coordination and communications with the vendors, Vendor Qualification Group and applicable cross functional departments (including site QA and sourcing teams) for vendor qualification and vendor audit related activities.To perform and track the vendor audits for on time execution as per plan, review of compliance reports and maintain the database for vendor audit CAPAs while ensuring necessary tracking and follow-up of open CAPAs for their timely closure.Preparation and review of risk based assessment (RBA) and other necessary documentation for periodic audits/unscheduled audits and ensuring that vendor assessments/evaluations are timely documented and communicated.Preparation, review and archival of GMP documents related to vendor auditing and vendor qualification.To prepare the data for Monthly Review Meeting, CFT Meeting and other Quality Meetings related to vendor qualification activities and coordination for Management Reviews and escalations as per requirement. Preparing minutes of meeting and keeping track of activities in account of these quality meetings. To approve, disapprove, extend, and update the Q-info (Vendor / Material) and updation of the audit scheduler in SAP.To create and upload the documents related to vendor qualification and vendor audits in SAP system and to maintain the audit scheduler.