<ul><li>Review and approve BMRs, BPRs, and other GMP documents related to sterile manufacturing.</li><li>Conduct in-process quality assurance checks and line clearances in cleanroom environments.</li><li>Monitor aseptic operations and ensure adherence to sterile area protocols and gowning procedures.</li><li>Handle deviations, change controls, CAPA, and risk assessments as per QMS.</li><li>Participate in validation and qualification of sterile processes, equipment, and areas.</li><li>Support media fill (aseptic process simulation) activities and review results.</li><li>Conduct training on GMP, data integrity, and aseptic techniques for operations teams.</li><li>Prepare and maintain quality metrics, audit readiness, and compliance reports.</li></ul>

Sr. Executive-Quality Assurance (Sterile)