Sr Executive-Analytical Quality Assurance

Role Overview: As a Senior Executive - AQA at Jubilant Pharmova Limited in Nanjangud, Mysore, you will play a crucial role in ensuring analytical compliance in alignment with regulatory guidelines, monograph requirements, customer needs, and internal procedures. Your responsibilities will involve reviewing laboratory metrics to identify areas for improvement, ensuring right first-time laboratory performance, and overseeing various quality management system processes such as OOS, OOT, deviations, change management, incidents, CAPA, and effectiveness checks. Additionally, you will be responsible for reviewing and approving SOPs, specifications, analytical procedures, and conducting training on laboratory management and CAPA implementation. Key Responsibilities: - Ensure analytical compliance with regulatory guidelines, monograph requirements, and customer specifications. - Review laboratory metrics to identify opportunities for improvement and enhance laboratory compliance. - Review and approve various quality management system documents such as OOS, OOT, deviations, change management, incidents, CAPA, and effectiveness checks. - Review and approve SOPs, specifications, analytical procedures, and analytical work orders. - Ensure timely completion of quality management system events. - Handle management and customer notifications. - Participate in customer audits and regulatory audits, as well as conduct internal audits and unscheduled audits when necessary. - Review and approve instrument qualification, method validation/transfer/verification, and risk assessment reports. - Implement CAPAs to prevent recurrence of quality events and ensure compliance with regulatory assessments. - Take on any additional assignments delegated by the reporting manager. - Fulfill tactical/operational responsibilities delegated in the absence of the position holder's manager. Qualification Required: - Bachelor's or Master's degree (B. Tech. / M.Tech) in any specialization related to Chemistry, Chemical, PCM, or Chemistry. - Minimum of 4+ years of relevant experience in the API industry.,