<ul><li>Review and approve analytical data generated by the QC department.</li><li>Ensure compliance of test methods, specifications, and protocols with regulatory requirements.</li><li>Perform analytical data verification, including chromatograms and calculations.</li><li>Conduct review of stability data, validation reports, and OOS/OOT investigations.</li><li>Monitor laboratory practices to ensure adherence to GLP and cGMP.</li><li>Coordinate with QC for timely resolution of analytical discrepancies.</li><li>Support method validation, transfer, and change control processes.</li><li>Prepare and maintain QA documentation related to analytical quality.</li></ul>

Analytical QA