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Officer – Fill Finish Facility (Pune Biotech, MH, IN) @ Lupin Limited

Pune Biotech, MH, INOnsiteFull-time
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About this role

<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Long Description</H2> </div><div><ol> <li>Execute and supervise <strong>100% visual inspection</strong> of prefilled syringes (PFS) and vials in accordance with approved SOPs and defined inspection standards.</li> <li>Maintain accurate, real-time documentation in <strong>BMR/BPR, equipment logbooks, inspection records, and rejection records</strong>.</li> <li>Execute and supervise <strong>training of inspectors and operators</strong> on defect identification, defect classification, and inspection techniques.</li> <li>Evaluate <strong>inspector performance</strong>, manage inspector fatigue, and ensure strict adherence to approved SOPs.</li> <li>Ensure discipline, proper <strong>gowning compliance</strong>, and acceptable <strong>cleanroom behavior</strong> in the inspection area.</li> <li>Ensure compliance with <strong>data integrity (ALCOA+) principles</strong> throughout inspection and documentation activities.</li> <li>Review inspection data and ensure accurate <strong>reconciliation of inspected, accepted, rejected, and destroyed quantities</strong>.</li> </ol></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Education</H2> </div><div><div>Graduation in Pharmacy</div><div>Post Graduation in Biotechnology</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Work Experience</H2> </div><div><div>Minimum 2 to 4 years of relevant experience in visual inspection of sterile injectable Vial and PFS products, along with proven experience in handling and facing regulatory audits.</div></div></div></div>

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