<p>Job Responsibilities</p>

<ul>
	<li>Perform in-process checking in granulation, compression, coating and packing area including documentation .</li>
	<li>Investigation of market complaint, deviation management, product recall, reporting and documentation.</li>
	<li>To prepare SOP and conduct training on the SOP.</li>
	<li>Handling change control as per corporate guideline.</li>
	<li>Preparing of annual product review.</li>
	<li>Issuance of process validation, cleaning validation and hold time study protocol and monitoring the validation activities and preparation of validation report in timely manner.</li>
	<li>Issuance of machine qualification protocol and monitoring of qualification and requalification activities and preparation of qualification report in timely manner.</li>
	<li>To execute project/product transfer / Technology transfer / Pharmacopeia Change management.</li>
	<li>To issue and review of all master documents (e.g. BMR/BPR, SOP, STP, Form, Checklist Template etc.) and other formats.</li>
	<li>To review and investigation OOS, OOT and other lab events.</li>
	<li>To perform risk assessment guideline as and when required on identified events.</li>
	<li>Review of batch documents after completion of production and QC activities and release of product to market.</li>
</ul>