QC Qualification Engineer
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<td style="width:622px"><p><strong>Job Purpose </strong> </p></td>
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<td style="height:18px; width:622px"><p> </p><p>The Qualification Engineer provides strong knowledge, experience and competency to ensure equipment are commissioned, qualified and/or validated and maintained in compliance with internal quality systems & standards (e.g. asset change controls, qualification, SOPs) and fully meet expectations of internal (GCA) and external authorities (FDA, HSA< EMA etc). He/she maintains close interface with all support units (i.e. QA, QC and HSE) to ensure equipment is maintained and re-qualified as needed, to be in constant state of compliance with quality systems to support safe manufacturing operations.</p></td>
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<td style="width:619px"><p><strong>Key Accountabilities</strong> </p></td>
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<ul><li>Responsible for writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system).</li><li>Responsible for execution of IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system).</li><li>Manage and maintains the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team.</li><li>Coordinate and manage deviation to be initiated, assessed and closed out in timely manner.</li><li>Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity.</li><li>Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.</li><li>Handover and coordination post LEQ execution to QC lab.</li></ul>
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<td style="width:619px"><p><strong>Performance Indicator </strong></p></td>
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<ul><li>Delivery of results in time and in accordance to quality</li><li>Project on track according to plan and quality expectations</li><li>Demonstrate the ability to work successfully as a member of a multi-discipline team</li><li>Demonstrate excellent written and oral communication skills</li><li>Adherence to cGMP and HSE guidelines and procedures</li></ul>
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<td style="width:619px"><p><strong>Ideal Background </strong></p></td>
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<td style="height:16px; width:207px"><p><strong>Education </strong>(minimum/desirable):</p></td>
<td style="height:16px; width:422px"><p>Minimum BS in Biotechnology, Chemistry or Pharmaceutical Engineering</p></td>
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<td style="height:8px; width:207px"><p><strong>Languages: </strong></p></td>
<td style="height:8px; width:422px"><p>English - fluent in speaking and writing.</p></td>
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<td style="height:29px; width:207px"><p><strong>Experience:</strong> </p></td>
<td style="height:29px; width:422px"><p>• Minimum 5 years of Biotech or Pharmaceutical cGMP experience is required.</p><p>• Related experience in supporting an operational quality control laboratory.</p><p>• Working experience with Lab Equipment Qualification and Computerized System Validation is required.</p></td>
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Apply for this position
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<tr>
<td style="width:622px"><p><strong>Job Purpose </strong> </p></td>
</tr>
<tr>
<td style="height:18px; width:622px"><p> </p><p>The Qualification Engineer provides strong knowledge, experience and competency to ensure equipment are commissioned, qualified and/or validated and maintained in compliance with internal quality systems & standards (e.g. asset change controls, qualification, SOPs) and fully meet expectations of internal (GCA) and external authorities (FDA, HSA< EMA etc). He/she maintains close interface with all support units (i.e. QA, QC and HSE) to ensure equipment is maintained and re-qualified as needed, to be in constant state of compliance with quality systems to support safe manufacturing operations.</p></td>
</tr>
</tbody>
</table>
<p> </p>
<table border="1" cellpadding="0" cellspacing="0" style="width:619px">
<tbody>
<tr>
<td style="width:619px"><p><strong>Key Accountabilities</strong> </p></td>
</tr>
<tr>
<td style="width:619px"><p> </p></td>
</tr>
</tbody>
</table>
<ul><li>Responsible for writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system).</li><li>Responsible for execution of IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system).</li><li>Manage and maintains the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team.</li><li>Coordinate and manage deviation to be initiated, assessed and closed out in timely manner.</li><li>Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity.</li><li>Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.</li><li>Handover and coordination post LEQ execution to QC lab.</li></ul>
<p> </p>
<table border="1" cellpadding="0" cellspacing="0" style="width:619px">
<tbody>
<tr>
<td style="width:619px"><p><strong>Performance Indicator </strong></p></td>
</tr>
</tbody>
</table>
<p> </p>
<ul><li>Delivery of results in time and in accordance to quality</li><li>Project on track according to plan and quality expectations</li><li>Demonstrate the ability to work successfully as a member of a multi-discipline team</li><li>Demonstrate excellent written and oral communication skills</li><li>Adherence to cGMP and HSE guidelines and procedures</li></ul>
<p> </p>
<table border="1" cellpadding="0" cellspacing="0">
<tbody>
<tr>
<td style="width:619px"><p><strong>Ideal Background </strong></p></td>
</tr>
</tbody>
</table>
<p> </p>
<table border="0" cellpadding="0" cellspacing="0" style="width:628px">
<tbody>
<tr>
<td style="height:16px; width:207px"><p><strong>Education </strong>(minimum/desirable):</p></td>
<td style="height:16px; width:422px"><p>Minimum BS in Biotechnology, Chemistry or Pharmaceutical Engineering</p></td>
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<td style="height:16px; width:207px"><p> </p></td>
<td style="height:16px; width:422px"><p> </p></td>
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<td style="height:8px; width:207px"><p><strong>Languages: </strong></p></td>
<td style="height:8px; width:422px"><p>English - fluent in speaking and writing.</p></td>
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<td style="height:8px; width:207px"><p> </p></td>
<td style="height:8px; width:422px"><p> </p></td>
</tr>
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<td style="height:29px; width:207px"><p><strong>Experience:</strong> </p></td>
<td style="height:29px; width:422px"><p>• Minimum 5 years of Biotech or Pharmaceutical cGMP experience is required.</p><p>• Related experience in supporting an operational quality control laboratory.</p><p>• Working experience with Lab Equipment Qualification and Computerized System Validation is required.</p></td>
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