Assistant Manager - GLP

<table class="MsoNormalTable" border="0" cellspacing="0" cellpadding="0" width="663" style="width:497.6pt;margin-left:-8.8pt;"> <thead> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><b><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Sr.</span></b></p><p><b></b></p><b></b> <p class="MsoNormal"><b><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">No.</span></b></p><p><b></b></p><b></b> </td> <td width="616" style="width:462.1pt;border:solid 1pt;border-left:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><b><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Job Responsibilities</span></b></p><p><b></b></p><b></b> </td> </tr> </thead> <tbody><tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">1</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Prepare, Revise CQ Documents (i.e., Policy, Standard Practices, Directive, SOP and GTPs) related to QC function, based on the identified GAPs and current requirement.</span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">2</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To Implement the Corporate Procedures (i.e., Policy, Standard Practices, Directive, SOP and GTPs) at Sites and Verify the Site Procedures against the implemented corporate procedures for the gaps, if any and ensure compliance on identified gaps. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">3</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Assessment of QC Specific 483’s issued to other companies and identify the Global CAPA for further prevention of same observations at Zydus Sites (whenever needed).</span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">4</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">On Site/Off Site Verification of Global CAPA / Compliance of Quality Intelligence observations at the Drug Manufacturing Sites of Zydus Lifesciences Ltd and its Subsidiaries. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">5</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Trend QC Investigations (e.g., OOS and Laboratory Incident) and recommend Global/Site Specific CAPA, if deemed necessary based on trend reports. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">6</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">Perform Quality Control Laboratory Walkthroughs, observe the practices and provide feedback for necessary training elements / revise the procedures etc. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">7</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To provide training to site personnel (QC/QA) related to QC investigation and/or other QC practices, as when as needed. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">8</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To review the Quality Control data as when as needed. </span></p><p></p> </td> </tr> <tr> <td width="47" valign="top" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">9</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To evaluate, review and implement the automated instrument for Quality Control Laboratory </span></p><p></p> </td> </tr> <tr> <td width="47" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">10</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To carry out the Proof of Concept (POC) for Automated instrument and QC Automation </span></p><p></p> </td> </tr> <tr> <td width="47" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">11</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To conduct the qualification of software for QC activities automation within the scope of computer system validation (CSVMP)</span></p><p></p> </td> </tr> <tr> <td width="47" style="width:35.5pt;border:solid 1pt;border-top:none;padding:0cm 5.4pt 0cm 5.4pt;"> <p class="MsoNormal"><span lang="en-us" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">12</span></p><p></p> </td> <td width="616" style="width:462.1pt;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" style="font-size:11pt;font-family:Calibri, sans-serif;" xml:lang="en-us">To ensure implementation of Automation, provide training to site team and provide support for troubleshooting activities, whenever required.</span></p><p></p> </td> </tr> </tbody></table>