Qualification and Validation Lead - Chennai

<h4>Job Description</h4><div> <p> <b> Role Summary: </b> </p> <ul> <li> Responsible to perform qualification and validation activities of all pharmaceutical laboratory equipment s. </li> <li> Responsible to perform System audit trail, user management & periodic review. </li> <li> Must have experience in equipment/instrument qualification/validation 10-15 years in pharmaceuticals industry</li> </ul> <p> <b> ROLE RESPONSIBILITIES & SKILL SETS</b> </p> <ul> <li> Must be familiar in IQ/OQ/PQ execution and developing qualification protocols of Analytical equipment/instruments. </li> <li> Should be familiar in identifying qualification deliverables as per AIQ. </li> <li> Should be familiar in DI/ERES concepts. </li> <li> Should be familiar in requirements of RA, DQ, IQ/OQ/PQ, SAT, FAT, UAT</li> <li> Should have working knowledge on Valgensis. </li> <li> Should possess in depth knowledge on Periodic review concepts and its requirements. </li> <li> Should have working knowledge on laboratory equipment like Chromatography systems (HPLC, GC, UPLC etc), MS, Titrators, Balances, Autoclave, stability chambers, lyophilizes etc. </li> <li> Must possess good knowledge in Enterprise software like Empower, chromeleon etc</li> <li> Responsible to co-ordinate with vendors for qualification/commissioning</li> <li> Responsible to perform validation for standalone software</li> <li> Responsible for designing calibration, and preventive maintenance schedules based on equipment complexity. </li> <li> Responsible to maintain Equipment qualification related documents for Audit purpose. </li> <li> Should able to perform periodic Audit trail and user management review for computerized and Non-computerized systems. </li> <li> Must possess through Knowledge on GxP concepts</li> <li> Must be familiar in Handling of Deviations/ Incident, Change controls and Investigations etc in Trackwise system. </li> <li> Should possess In depth knowledge in 21CFR part 11 compliance and requirement</li> <li> Knowledge on analytical equipment calibration and maintenance will be an added advantage. </li> <li> Must be familiar on regulatory requirement like 21 CFR, EU annexure 11 etc. (link removed) and GAMP concepts. </li> <li> Should possess good negotiation skills. </li> <li> Possessing knowledge in Asset manager would be added advantage. </li> <li> Responsible to manage the team. </li> </ul> <p> <b> Educational Qualifications:</b> </p> <ul> <li> B. E/B. Tech ( CS, IT, EEE, EIE)</li> <li> B. Pharm/M. Pharm</li> </ul> <br> Work Location Assignment: On Premise<br> <p> </p> <p> <span> <span> <span> <span> <span> <span> <span> <span> <span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </p> <p> </p> <p> </p> Engineering<p> </p> <p> </p> </div><h4>Job Classification</h4><b>Industry: </b>Pharmaceutical & Life Sciences</br><b>Functional Area: </b>Pharmaceutical & Life Sciences</br><b>Role Category: </b>Quality Assurance - Other </br><b>Role: </b>Quality Assurance - Other</br><b>Employement Type: </b>Full time</br><h4>Contact Details:</h4><b>Company: </b>Pfizer</br><b>Location(s): </b>Chennai</br><b>