<ul><li>Review of data and reports related to the sample analysis, pharmacokinetic &amp; statistical analysis reports and bioanalytical method validation reports. To conduct in process audits for study as well as method validation.</li><li>Review of calibration / validation documents and COAs of working / reference standards.</li><li>Preparation and review of SOPs.</li><li>Conduct system audits in relevant departments and conduct vendor audit.</li><li>Maintain master documents, calibration certificate and validation document related to laboratory</li><li>Ensure training of all applicable personnel involved during study activities.</li><li>Ensure implementation of CAPA response.</li><li>Issuance and archival of documents.</li></ul>

Officer / Sr. Officer - QA / QC ( BA Lab )