<ul><li>Documentation, QMS Documentation, Validation, qualification, deviation, change control etc.</li><li>MFR/SOP/AMV (analytical Method Validation), ACTD/CTD, Dossier Preparation.</li><li>Knowledge of COPP.</li><li>Having a sound knowledge of BMR preparation and filing, FR&amp;D Documentation, PV ETC Monitoring of process validation activity with preparation of protocol and report.</li><li>Monitoring of cleaning validation activity with preparation of protocol and report.</li><li>Review the Qualification document of equipment and facility.</li><li>Review of instrument and equipment calibration.</li><li>Review and monitoring of Revalidation of process and requalification of equipment/instrument.</li></ul>

Executive / Sr. Executive QA - QMS