To Lead the Team and coordination with production activity. - To ensure day to day QA controls are at place and make QA empowered for the entire plants - To ensure timely calibration, preventive maintenance and qualification/ validations of all equipment’s / instruments. Track the audit observations and send compliance reports in stipulated time. To approve and batch release after completion and review of all relevant documents with in time line. - To approve / authorize all master documents… Show more To Lead the Team and coordination with production activity. - To ensure day to day QA controls are at place and make QA empowered for the entire plants - To ensure timely calibration, preventive maintenance and qualification/ validations of all equipment’s / instruments. Track the audit observations and send compliance reports in stipulated time. To approve and batch release after completion and review of all relevant documents with in time line. - To approve / authorize all master documents like SOP’s, Formats and Exhibits, Master Formula cards, Master Batch Manufacturing and packing records, customer related quality documents etc. and ensure that all are updated to date. To Review the URS, DQ, IQ, OQ, and PQ Protocol and report. - To Coordination with engineering and involvement in qualification and validation activities when it is going on. - To review the certificate receipt from third party validation. - To review Quality Management Document. - To review the documents as current SOP and regulatory requirements. - To participate in customer and regulatory bodies audit activity. - Self-inspection and / or quality audit, which regularly appraises the effectiveness and applicability of the QA system. - To Handle and review of critical quality functions such as deviations, change controls, failure investigation, annual product quality reviews, training handling and to take proactive actions. - To ensure CAPA effectiveness at site and every time readiness for audit. - To Responsible for Identifications, assessment and mitigation of quality risk at assigned sites. - To investigate quality failure events and resolution of product related deviations. - To perform GAP analysis and track with proper QMS. Implementation of Quality system on shop floor. - To independently Handling of Vendor Qualification (manufacturer & suppliers) supplying raw and packaging materials. - To ensure timely preparation of audit reports and review of responses/ compliance. Show less