<ul><li>Review and approve batch manufacturing records (BMR) and batch packing records (BPR).</li><li>Perform line clearance in sterile areas before manufacturing and packing activities.</li><li>Ensure compliance with cGMP, SOPs, and regulatory guidelines in sterile operations.</li><li>Monitor aseptic practices, environmental conditions, and cleanroom behaviors.</li><li>Participate in investigations of deviations, incidents, and change controls.</li><li>Coordinate with QC and production for timely documentation and batch release.</li><li>Maintain documentation related to validation, qualification, and product quality reviews.</li><li>Support media fill observations, audit preparedness, and regulatory inspections.</li></ul>

Quality Assurance Sterile Officer