<ul><li>Oversee all laboratory Quality Assurance activities, ensuring compliance with GMP, GLP, and regulatory requirements.</li><li>Review and approve analytical documents, COAs, test reports, and laboratory records.</li><li>Monitor QC lab operations, including method validation, calibration, and stability studies.</li><li>Ensure adherence to SOPs and implement updates or new SOPs when required.</li><li>Lead investigations for OOS, OOT, deviations, and ensure effective CAPA implementation.</li><li>Coordinate with QC, Production, R&amp;D, and Regulatory for quality-related matters.</li><li>Review and ensure compliance of laboratory data integrity and documentation practices.</li><li>Support internal and external audits, ensuring readiness of laboratory and QA documentation.</li><li>Train and mentor QA/QC team members on quality systems and regulatory guidelines.</li></ul>

Assistant Manager-QA (Lab)