<ul><li>Prepare/Review the Protocol, Informed Consent Documents (ICD) (English), Case Report Form (CRF) and/or associated working documents related to study, as per SOP and applicable regulatory guidelines.</li><li>Review of Clinical study report (CSR) with all appendices, final e-CTD/CTD, as per SOP and applicable regulatory guidelines.</li><li>Review of SOPs, Project summary and other documents prepared by BPD team</li><li>Ensure that necessary actions are taken for the rectification and all the findings/comments/suggestions are resolved.</li><li>Coordinate with Head – Biopharmaceutics and team for preparing new SOP as well as revising current SOP to upgrade the system.</li><li>Understanding of various regulatory requirements (Guidance) like USFDA, EMA, Canada, ANVISA, DCGI, TGA etc.</li><li>Review of documents generated after sponsor comment, regulatory observation and ensures compliance to the same.<br>Perform any other duties as assigned by Group Leader / Head-Biopharmaceutics and Project Management<br>&nbsp;</li></ul>

Quality Control