Team Member - Microbiology
Cipla · Rangpo
Collected role description
<span class="jobdescription"><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">Division</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">Department</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">Sub Department 1</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">Job Purpose</H2> </div><div><p style="margin-bottom:4.0px;margin-top:5.0px;text-align:justify"><span style="font-size:10.0pt"><span><span style="font-family:Arial, sans-serif">Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards.</span></span></span></p> </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">Key Accountabilities (1/6)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Analyse and review samples based on work allocation to meet the service level agreement</span></span></b></p>
<ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Analyse samples as per priority and work allocation</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Review the data as per respective specification, Microbiological Methods and results obtained</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA</span></span></li> </ul> </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">Key Accountabilities (2/6)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases </span></span></b></p>
<ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Initiate investigations and take necessary corrective and preventive actions</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring</span></span></li> </ul> </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">Key Accountabilities (3/6)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries </span></span></b></p>
<ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Review reports as per cGMP & GDP for compliance to GLP</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures</span></span></li> </ul> </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">Key Accountabilities (4/6)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same</span></span></b></p>
<p><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments</span></span></p> </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">Key Accountabilities (5/6)</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">Key Accountabilities (6/6)</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">Major Challenges</H2> </div><div><ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites.</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA</span></span></li> </ul> </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">Key Interactions (1/2)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Internal</span></span></b></p>
<ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif"><b>Units</b> for receiving specification, documents, protocols, area availability etc. (daily)</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif"><b>QA/QC</b> for product sample release (daily)</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif"><b>Stores </b>for procuring materials<b> </b>(need basis)</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Communicate if any observation find on the specification</span></span></li> </ul> </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">Key Interactions (2/2)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">External</span></span></b></p>
<p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">CQA </span></span></b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">for procuring pharmacopial guidelines (need basis)</span></span></p> </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">Dimensions (1/2)</H2> </div><div><ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Review and release approximate 15 MLT reports on daily basis to achieve the SLA.</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples. </span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">50 Water Samples analysis and release</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">10 Technical Information Sheets for swap analysis</span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">6 Autoclave & DHS Operation </span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">200 locations released on daily basis for Environmental monitoring</span></span></li> </ul> </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">Dimensions (2/2)</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">Key Decisions (1/2)</H2> </div><div><p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Recommendations</span></span></b></p>
<p><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Daily Media and Plates requirement (to Team Leader Microbiology)</span></span></p> </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">Key Decisions (2/2)</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 Qualification</H2> </div><div><p><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">M. Sc (Microbiology)</span></span></p> </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">Relevant Work Experience</H2> </div><div><ul style="margin-bottom:5.0px;margin-top:5.0px"> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:Arial, sans-serif">1-5 years’ experience for analyst and 3-7 years for reviewer in Microbiology </span></span></li> <li style="text-align:justify"><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif">Good knowledge of Microbiology, skill to perform assigned task, communication in English</span></span></li> </ul> </div></div></div> </span>
Collected experience requirement
1-5 years