Associate Manager - CQ - Informatics

<p class="MsoNormal"></p><p> </p><table class="MsoNormalTable" border="1" cellspacing="0" cellpadding="0" width="669" style="width:501.55pt;border-width:medium;border-style:none;"> <tbody><tr> <td width="54" style="width:40.85pt;border:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal" align="center" style="text-align:center;"><b><span lang="en-us" xml:lang="en-us">Sr. No.</span></b></p><p><b></b></p><b></b> </td> <td width="614" style="width:460.7pt;border:solid 1pt;border-left:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoHeader" align="center" style="text-align:center;"><b><span lang="en-us" xml:lang="en-us">Job Responsibilities</span></b></p><p><b></b></p><b></b> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 and review central guidance/policies/SOPs for computerized system</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 validation plan, Validation summary report and System release certificate of centralized GxP software</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 review and approve software validation deliverables of centralized GxP software</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 review change controls, Deviation and CAPA of centralized GxP software</span></p><p></p> </td> </tr> <tr style="border-left:1px solid #000000;height:21.85pt;"> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;height:21.85pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;border-top:none;border-left:none;border-bottom:solid 1pt;border-right:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;height:21.85pt;"> <p class="MsoNormal"><span lang="en-us" xml:lang="en-us">To carryout software supplier assessment for centralized GxP software</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 coordinate and conduct training programs and workshop (internal and external) on current cGMP trend, central quality policy, standard practice and directive as and when required.</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 perform review of computerized systems document with respect to established procedures and current regulatory requirements to assist site user for compliance</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><b><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', serif;" xml:lang="en-us"> </span></b><b> </b><p><b> </b></p><b> </b></td> <td width="614" valign="top" style="width:460.7pt;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 ensure shop floor IT compliances at sites such as compliance of IT Standard Operating Procedure, User Access Management, Data center Qualification and Network Qualification.</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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 perform onsite verification of Global CAPA/ Informatics/Quality Intelligence points for computerized system </span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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 support to the sites for Regulatory Audit preparation </span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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 Providing resolution for queries related to computerized system </span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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 proactively identify emerging cGMP requirement with respect to computerized system and implementation as and when required.</span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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 perform gap assessment related to Computerized system with respect to regulatory guideline, US FDA 483 form, USFDA warning letter </span></p><p></p> </td> </tr> <tr> <td width="54" valign="top" style="width:40.85pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"><span lang="en-us" style="font-size:12pt;font-family:'Times New Roman', 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="614" valign="top" style="width:460.7pt;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">Preparation of informatics status reports for the management as and when required.</span></p><p></p> </td> </tr> </tbody></table>