Executive Quality Assurance

Year Paonta Sahib, Himachal Pradesh, India

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Initiation, Review and Approval of SOPs, Specifications, STPs in DCM.
Initiation, of Specifications, STPs in Laboratory information management system.
Approval of Artwork and Vendor Proof in Artwork Management System (AMS).
Review and Approval of All document related to vendor management.
Initiation & review of Vendor Qualification documents, QM/QI view requests, Code to Code Transfer Requests, Specification Linkage Requests and Shelf-life and retest period extension.
Preparation of Product Risk Assessment Report.
Initiation, Review & Approval of Change Management.
Initiation & QA review of Deviation Management.
Timely completion of investigations and reports on Market Complaints, change controls, Product Recall, OOS, Deviations and their Compliance.
Handling of Market complaints and Product Recall.
Queries response to QP/Customers.
Compliance to CAPA implementation if any given in the APR against any recommendation.
Vendor Risk Assessment.
Preparation of Annual Product Review and timely closure of Annual product review.

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