<ul><li>Prepare, review, and maintain Standard Operating Procedures (SOPs), batch manufacturing records (BMR), and batch packaging records (BPR).</li><li>Manage change control, deviation reports, incident investigations, and CAPA (Corrective and Preventive Actions).</li><li>Ensure proper documentation and archiving of quality records in adherence to GDP.</li><li>Participate in internal and external audits, including regulatory and customer audits.</li><li>Ensure audit readiness and provide the necessary documentation during inspections.</li><li>Assist in drafting audit responses and follow up on the implementation of recommendations.</li><li>Monitor production activities to ensure adherence to quality standards and regulatory requirements.</li><li>Conduct in-process quality checks and provide real-time feedback to the production team.</li><li>Identify non-conformance issues and escalate them to the QA Manager for resolution.</li></ul>

Officer/Sr. Officer-QA