<ul><li>To conduct study specific in-process and retrospective audits of Clinical projects (BA/BE Studies for a CRO) including eCTD and CDISC.</li><li>Preparation of audit reports, receiving of the responses and verification &amp; follow-up of the corrective/ preventive actions and issuance of audit certificate.</li><li>Checking and issuing of clinical study related label sheets.</li><li>Release of the subject concentration to the Bio-statistics department for further analysis and report generation.</li><li>To assist and coordinate during the external audits by sponsor/clients and regulatory audits.</li><li>Review of instrument/equipment qualification documents, Calibration records.</li><li>Form issue and control of documents.</li><li>Submission of QA documents for archival.</li></ul>

Executive / Sr. Executive - Quality Assurance