Senior Executive - Manufacturing QA

<h2><b>Job Description:</b></h2><p>Qualification: M. Pharmacy / B. Pharmacy with a minimum of 12&#43; years of experience in Shop floor QA, Investigation, QMS activities, Qualification-Validation and APQR activity.</p><p><span><span>·<span>       </span></span></span>Responsible for End-to-End Shop Floor activity, monitoring process controls, active involvement in quality investigations.</p><p><span><span>·<span>       </span></span></span>Responsible for Batch record review and release of Batch.</p><p><span><span>·<span>       </span></span></span>Responsible for Preparation of APQR and CPV, identification of abnormal trend and mitigation of same.</p><p><span><span>·<span>       </span></span></span>Responsible for review of Process / Packing Validation and Technology Transfer Protocols and Reports.</p><p><span><span>·<span>       </span></span></span>Review of QMS (i.e. Change Controls, Deviations, Investigations, CAPA, OOS and OOT reports)</p><p><span><span>·<span>       </span></span></span>Review of Cleaning Validation, Hold Time of Product Intermediate, DEHT / CEHT Studies.</p><p><span><span>·<span>       </span></span></span>Review of Apex SOPs / Preparation of QA related SOPs.</p><p><span><span>·<span>       </span></span></span>Active involvement in the Sampling process.</p><p><span><span>·<span>       </span></span></span>Review of Qualification, Validation and CSV activities</p><h2><b>Location:</b></h2>Ferring India Laboratories