Manager-QA
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As an FDA-approved Quality Assurance professional with over 13 years of experience in Quality Assurance, Analytical, API & formulation Manufacturing, and R&D formulations, I have honed my expertise in ensuring compliance with regulatory standards and driving operational excellence. Currently serving as a team manager, I have successfully led cross-functional teams and implemented quality improvement initiatives that have enhanced product quality and streamlined processes. With a proven track record of delivering results, I am passionate about leveraging my skills and experience to drive business success and ensure customer satisfaction.
Manage and monitor the QA team of 6 associates for the US FDA-approved analytical lab and R&D formulation. Prepare for all Enaltec sites for inspection readiness, DI and gap assessment. Support and coordinate with the regulatory and CMO team for ANDA filling.
Well-acquainted with review, assessment, investigation and approval of all QMS such as OOS/ OOT, Change Control Management, Incident & Deviation management, and CAPA management. Review and approval of Product Development Reports (PDR), Batch Manufacturing Reports (BMR), Master Formula Cards (MFC) and other Formulation data. Supervise, review and approve CSV activities.
Prepare for and lead client, vendor, and regulatory audits. Evaluate vendor qualifications and conduct audits for API manufacturing and testing facilities. Ensure the quality management system is implemented and updated.
Supervise and approve quality activities and technology transfers. Review and support analytical methods, calibration data, batch release data, Validation Protocol/ Reports, Qualification Protocol/ Reports and stability protocol/data. Handle complaints and recalls, and review/support QMS trending.
Maintain GMP documentation, SOPs, specifications, protocol/reports, and formulation data. Communicate with internal and external stakeholders for QA matters. Manage SOP implementation & approval, and archive relevant documents.
Conduct team training and development, and ensure effective communication and collaboration within the team.
Master in chemistry from Madurai Kaamraj University.
