Associate Manager - QMS Central Quality

<p class="MsoNormal"></p><p> </p><table class="MsoNormalTable" border="0" cellspacing="0" cellpadding="0" width="709" style="width:531.6pt;margin-left:-15.9pt;"> <tbody><tr> <td width="66" style="width:49.65pt;border:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><b><span lang="en-us" xml:lang="en-us">Sr. No.</span></b></p><p><b></b></p><b></b> </td> <td width="643" style="width:17cm;border:solid 1pt;border-left:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><b><span lang="en-us" xml:lang="en-us">Job Responsibilities (QMS-Sterile Injectables) </span></b></p><p><b></b></p><b></b> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="1" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Overview of site QMS documents as per SOP “Overview of Quality Management system documents by CQ” to verify its adequacy and completeness.</span></p><p></p> <p class="MsoNormal"><b><span lang="en-us" xml:lang="en-us"> </span></b></p> <p class="MsoNormal"><b><span lang="en-us" xml:lang="en-us">QMS ELEMNETS TO BE REVIEWED INCLUSIVE OF : </span></b></p><p><b></b></p><b></b> <ul style="margin-top:0cm;" type="disc"> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">Deviations </span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">Process Investigations (OOS-Phase II)</span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">Change controls</span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">Qualification (Equipment and Utilities )</span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">Process validation </span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">APQR</span></b><p><b></b></p><b></b></li> <li class="MsoListParagraph" style="margin-left:0cm;"><b><span lang="en-us" xml:lang="en-us">QMS Trend report’s</span></b><p><b></b></p><b></b></li> </ul> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="2" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To prepare a report with appropriate categorizations and scaling of all actionable observations. </span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="3" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To discuss the gaps identified during review with site SME / QA Head / Lead Central Quality (LCQ) / Head Technical Operation (HTO) for resolution.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="4" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Review of site compliance report as applicable and follow ups for adequate closure through appropriate supporting documents from site.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="5" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Trend analysis of observation for identification of systemic areas for improvement.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="6" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Identify specific area of improvement based on emerging trend and provide / organize training to the site as and when required.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="7" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To prepare monthly reports and participate in departmental meeting.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="8" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To present summary of observations to Lead Central Quality (LCQ) / Head Technical Operation (HTO) and management on periodic basis.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="9" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To identify and escalate specific issue to management for compliance and support.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="10" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To assist in regulatory and external inspection for site readiness</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="11" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To present summary of observations to management on periodic basis.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="12" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To participate in periodic central quality audits to laid down quality systems taking holistic view on the product quality & patient safety; as & when required.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="13" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To provide concurrence to the audit observations & compliance as & when needed.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="14" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To assist in preparation / revision of Corporate SOPs, Guidelines & Policies when required.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="15" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Soft copy data management of reviewed documents.</span></p><p></p> </td> </tr> <tr> <td width="66" style="width:49.65pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us"> </span><ol style="margin-top:0cm;" start="16" type="1"> <li class="MsoNormal"><p> </p></li> </ol> </td> <td width="643" valign="top" style="width:17cm;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">Any additional activity assigned by HOD / Management.</span></p><p></p> </td> </tr> </tbody></table><p class="MsoNormal"></p><p> </p><p> </p><p class="MsoNormal"></p><p> </p>