Sr Executive-Analytical Quality Assurance

4 - 8 years

0 Lacs

Posted:4 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

You will be working as a Senior Executive - AQA at Jubilant Pharmova Limited located in Nanjangud, Mysore. Your role will involve the following key responsibilities: - Responsibility for analytical compliance in accordance with current regulatory guidelines, monograph requirements, customer needs, and internal procedures. - Reviewing laboratory metrics to identify areas for improvement in laboratory compliance and ensuring right first-time laboratory performance. - Reviewing and approving laboratory Quality Management System (QMS) documents such as Out of Specification (OOS), Out of Trend (OOT), Deviation, Change management, Incidents, Action items, Corrective and Preventive Actions (CAPA), Effectiveness Check, and related documents using Trackwise / SAP system. - Reviewing and approving Standard Operating Procedures (SOP), Specifications, methods of Analysis, General Testing Procedures, and Analytical Work Orders. - Ensuring timely completion of QMS events. - Managing Management and Customer notifications. - Participating in customer and regulatory audits, conducting internal audits, CTL audits, and unscheduled audits as required. - Reviewing and approving instrument qualification, Method validation/transfer/verification in QC. - Providing training on Laboratory management and participating in CAPA implementation. - Reviewing quality event trending and establishing CAPA to prevent recurrence. - Reviewing and approving risk assessment reports. - Implementing cross-deployed CAPA and CAPAs resulting from regulatory assessments in QC chemistry and Microbiology Labs. - Handling any other assignments as delegated by the reporting manager. - Assuming tactical/operational responsibilities in the absence of the position holder as delegated by the Manager. Qualifications required for this role: - B. Tech. / M.Tech (Any specialization) (Chemistry/Chemical/PCM/Chemistry) - Minimum 4+ years of relevant experience in the API industry. For more information about Jubilant Pharmova Limited, you can visit their website at www.jubilantpharmova.com.,

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