Lab QA (QA in QC , Micro SME)

<p class="MsoNormal"><b><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Job Details:</font></span></b></p><p class="MsoNormal"><font color="#000000"><span style="font-family:Calibri;font-size:14px;">Role: </span><span style="font-family:Calibri;font-size:14px;">Lab QA (QA in QC , Micro SME)</span></font></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Position: Senior Executive</font></span></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Report to: Lab QA Head</font></span></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Department: Quality Assurance</font></span></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Location: Moraiya</font></span></p><p class="MsoNormal"><b><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Requirements:</font></span></b></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Year of Experience: 7-10 years</font></span></p><p class="MsoNormal"><font color="#000000"><span style="font-family:Calibri;font-size:14px;">Experience in Zydus: </span><span style="font-family:Calibri;font-size:14px;text-align:justify;text-indent:-24px;">Minimum of 2 years in the same role at any formulation manufacturing site of Zydus in India. (minimum 2 performance rating in the current role)</span></font></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Technical skills required : MLT testing, validation, GPT, EM, culture identification, PET, DET</font></span></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Soft skills required : LIMS, eLIMS Track wise, DMS and basic computer applications.</font></span></p><p class="MsoNormal"><b><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Qualification:</font></span></b></p><p class="MsoNormal"><span style="font-family:Calibri;font-size:14px;"><font color="#000000">M.Sc/B.Pharma</font></span></p><p class="MsoNormal"><b><span style="font-family:Calibri;font-size:14px;"><font color="#000000">Key Job description:</font></span></b></p><p class="MsoListParagraphCxSpFirst" style="text-align:justify;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><table class="MsoNormalTable" border="0" cellspacing="0" cellpadding="0" width="584" style="width:438.1pt;"><tbody><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Monitoring of the compliance in the Microbiology Laboratory of Quality Control.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Lead QA SME for Microbiology to ensure daily compliance of the laboratory operations.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review of Microbiology Lab documents, reports such as Sterility test, BET, MLT related to FP, RM and stability samples.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review the documents of Microbiologist qualification, method validation, and disinfectant efficacy test.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review of SOPs, Specification, Trends of Environmental monitoring and Water, Validations / Qualification of an equipment and instrument.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Participate in the investigation of microbial excursion in microbiological lab.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review and evaluation of QMS documents like Deviation, Change controls, CAPA , Incident in microbiology lab.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Daily monitoring of lab activities and recording of QA observations.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review of microbiology department instruments Software audit trials. </span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Issuance and reconciliation of forms and formats through Documentum Software.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr><tr style="border-left:1px solid #000000;height:21.65pt;"><td width="584" nowrap="nowrap" valign="bottom" style="width:438.1pt;padding:0.75pt 0.75pt 0cm 0.75pt;height:21.65pt;"><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span><p class="MsoListParagraph" style="text-align:justify;text-indent:-18pt;"><font color="#000000"><span style="font-size:12pt;font-family:Symbol;"><span style="font-family:Calibri;font-size:14px;">·</span><span style="font-style:normal;font-variant:normal;font-size:14px;line-height:normal;font-family:Calibri;"> </span></span><span style="font-size:12pt;font-family:Aptos, sans-serif;"><span style="font-family:Calibri;font-size:14px;">Review of all microbiological related documents before submitting to IRA.</span></span></font></p><p></p><span style="font-family:Calibri;font-size:14px;"><font color="#000000"> </font></span></td></tr></tbody></table>