<ul><li>Preparation &amp; Compilation of registration dossiers for row, semi-regulated and regulated markets.</li><li>Collection of dossier documents from various departments like QC, QA, Stores, Production, FD, Stability and maintaining in a master document with systematic manner.</li><li>Submitting and reviewing the technical requirements for Tender Filing.</li><li>Review of specifications as per monographs. (USP/Ph.Eur).</li><li>Review of process qualification and product development records.</li><li>Review of stability data.</li><li>Review of innovator comparative dissolution data.</li><li>Review of all documents related to Formulation Development.</li><li>Art work review and approval.</li><li>Review, submission of quality dossiers as per the current guideline (country-specific) requirements and attending the MOH query.</li><li>Document follow up for FDA/Regulatory Queries.</li><li>Raising applications for product license, COPP, FSC as per requirement.</li><li>Communication with customer for the country specific registration requirements.</li><li>Arrangement of samples for registration purpose.</li></ul>

Production Officer