<ul><li>Review and approve manufacturing batch records, analytical reports, raw material specifications, finished product specifications, and other critical quality documents.</li><li>Oversee the effective management and control of all quality-related documentation, including SOPs, BMRs, Protocols, and Reports.</li><li>Actively participate in, and often lead, the investigation of deviations, non-conformances, and Out-of-Specification (OOS) results.</li><li>Facilitate Root Cause Analysis (RCA) to identify underlying causes of quality issues.</li><li>Propose, implement, and track Corrective and Preventive Actions (CAPA) effectively to prevent recurrence.</li><li>Monitor the effectiveness of implemented CAPAs.</li><li>Review and assess Change Control requests related to processes, equipment, materials, or documentation.</li><li>Ensure that all changes are properly documented, reviewed, approved, and implemented without compromising product quality or regulatory compliance.</li></ul>

Sr. Officer-Quality Assurance (IPQA)