Quality Auditor

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p><b>Core Job Responsibilities:</b></p><ul><li>Manage on-site audits for supplier and Third-party Manufacturers that provide materials/services to EPD..</li><li>All activities required to plan, prepare for, conduct, report and close the assigned audits.</li><li>Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.</li><li>Manage Quality Questionnaire for supplies and Third-Party Manufacturers</li><li>Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs evaluated.</li><li>Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD Auditing management, in line with the applicable policy and procedures.</li><li>Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolve any issues.</li><li>Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.</li><li>Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis. </li><li>Provide support to EPD plants in the timely resolution of issues related to suppliers.  Discuss with and agree with the supplier a timely implementation of corrective and preventive actions, as needed to prevent recurrence</li></ul><p></p><p><b>Minimum Education:</b></p><ul><li>Bachelor’s degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific), or industry experience with sufficient exposure to pharmaceutical or related industries.</li></ul><p></p><p><b>Minimum Experience/Training Required:</b></p><ul><li>At least 8 years in the Pharmaceutical/Healthcare Industry and/or Government Regulatory Agency; and at least 3 years of Auditing experience related to GMP, GDP or ISO for Pharma, Medical Devices and Nutritional product types</li><li>Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines.</li><li>Understanding of the WHO and other applicable regional and local regulations</li><li>Good Communication skills</li><li>Advanced written and verbal skills in Business English</li><li>Competencies required: adaptability, initiative, integrity, planning &amp; organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisiveness</li><li>Availability for traveling.</li></ul><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Operations Quality<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>China &gt; Shanghai : 388 W. Nanjing Road, Ciros Plaza<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>