Junior Team Member - Microbiology

<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>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.</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><strong>Analyse and review samples based on work allocation to meet the service level agreement</strong></p> <ul> <li>Analyse samples as per priority and work allocation</li> <li>Review the data as per respective specification, Microbiological Methods and results obtained</li> <li>Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA</li> </ul> <p> </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 (2/6)</H2> </div><div><p><strong>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 </strong></p> <ul> <li>Initiate investigations and take necessary corrective and preventive actions</li> <li>Investigate incidence &amp; lab error on priority basis so that batch release timely and issues are not recurring </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><strong>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 </strong></p> <p> </p> <ul> <li>Review reports as per cGMP &amp; GDP for compliance to GLP</li> <li>Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures</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><strong>Evaluate &amp; document Instrument / equipment break down and suggest mechanisms to avoid the same</strong></p> <p>Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments</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> <li>Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites.</li> <li>Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA</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><strong>Internal</strong></p> <ul> <li><strong>Units</strong> for receiving specification, documents, protocols, area availability etc. (daily)</li> <li><strong>QA/QC</strong> for product sample release (daily)</li> <li><strong>Stores </strong>for procuring materials<strong> </strong>(need basis)</li> <li>Communicate if any observation find on the specification.</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><strong>External</strong></p> <p><strong>CQA </strong>for procuring pharmacopial guidelines (need basis)</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> <li>Review and release approximate 15 MLT reports on daily basis to achieve the SLA.</li> <li>Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples.</li> <li>50 Water Samples analysis and release</li> <li>10 Technical Information Sheets for swap analysis</li> <li>6 Autoclave &amp; DHS Operation</li> <li>200 locations released on daily basis for Environmental monitoring</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><strong>Recommendations</strong></p> <p><strong>Daily Media and Plates requirement (to Team Leader Microbiology)</strong></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>M. Sc (Microbiology)</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 type="disc"> <li>1-5 years’ experience for analyst and 3-7 years for reviewer in Microbiology</li> <li>Good knowledge of Microbiology, skill to perform assigned task, communication in English</li> </ul></div></div></div> </span>