About this role
<table style="width:970.0px" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td colspan="4"> <table style="width:970.0px" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="background-color:white"><img src="https://career.bayer.com/sites/g/files/kmftyc1291/files/Internal%20Job%20Postings.jpg" border="0"></td> </tr> </tbody> </table> </td> <td> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> <p align="justify"> </p> <p align="justify"><span style="font-size:28.0px"><span style="font-family:arial, helvetica, sans-serif"><strong>GxP Audit Services Expert</strong></span> </span></p> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> </tbody> </table><p><span style="font-size:14.0pt"><strong>PURPOSE</strong></span></p> <ul> <li>Provide administrative support to the Quality Audits & Inspections internal auditors team.</li> <li>Support the preparation, reporting, follow up and closure of the audits across the PH-PS and CH-PS network in alignment with the Audit Program Manager (APM)</li> </ul> <p> </p> <p> </p> <p> </p> <p><span style="font-size:14.0pt"><strong>YOUR TASK AND RESPONSIBILITIES</strong></span></p> <ul> <li>Arrange audit preparation (audit dates alignment with the auditee and auditors, audit confirmation, updating IQMS, and others as aligned with the Audit Program Manager (APM)).</li> <li>Arrange pre-audit preparation (pre-meeting participants identification, dates alignment, invitations distribution, audit announcement, and others as aligned with the APM).</li> <li>Enter draft audit report in IQMS (audit details, reporting & summary, distribution lists completion, audit elements, observations)</li> <li>Distribute audit reports (draft audit report for revision to stakeholders (APM / auditee); distribute approved audit report including summary report; audit close out summary report, and others as aligned with the APM)</li> <li>Process minor corrections in draft audit report after the auditee revision (typographical errors, incorrect dates, changes in SOP numbers).</li> <li>Maintenance of audit record in IQMS (key audit information, CAPA plans, minor observations closure, audit-related record attachments, and others as aligned with the APM)</li> <li>Corrective and Preventive Action Plan (CAPA) maintenance (follow-up with auditees, monitoring, reporting, and closure of minor observations as advised by the APM).</li> <li>Maintenance of record in Audit and Inspection Monitoring System (assign AIMS ticket as needed, ensures up-to-date record, timely status monitoring of tickets assigned, escalation of any technical issues to the responsible person)</li> <li>Ensures timely compliance with the Service Level Agreement</li> <li>Perform quality reviews of GxP AS Critical Activities; act as the main reviewer</li> <li>Maintenance of Quality, Audit and Inspection Process controls</li> <li>Stakeholder Management: Issue resolution, Initiate clarification discussions</li> <li>Monitor team status and SLAs</li> <li>Regular reporting/alignment and escalation of any issues to Senior Expert and Lead, if necessary.</li> <li>Perform the regular review of QAI systems and processes including desktop procedures for compliance with the applicable stakeholder regulations</li> <li>Drive continuous process improvement for GBS Quality Audit Inspection stakeholders and internal initiatives</li> <li>Support internal and/or external audits or inspection when needed.</li> </ul> <p> </p> <p> </p> <p><span style="font-size:14.0pt"><strong>WHO YOU ARE</strong></span></p> <ul> <li>Professional experience (at least 3 years) in related fields.</li> <li>Administrative assistant experience highly appreciated.</li> <li>Familiar with the concept of KPIs. Experience working with KPIs is not mandatory but highly appreciated.</li> <li>Audit experience preferable but not mandatory.</li> <li>Experience with Veeva IQMS, not mandatory but highly appreciated.</li> <li>Ability to operate in a highly intercultural environment</li> <li>Communication skills. English language skills mandatory, any other language beneficial.</li> <li>Accuracy and organizational skills.</li> <li>Strong attention to detail</li> <li>Strong Customer Focus</li> <li>Strong Communication and Collaboration Skills</li> <li>Good Stakeholder Management</li> <li>Drives results</li> <li>Manages Complexity</li> </ul><table style="width:970.0px" border="0" cellspacing="0" cellpadding="0" align="left"> <tbody> <tr> <td colspan="3"> </td> </tr> <tr> <td colspan="3"> <p><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">Local regulations and legal requirements vary per country of hire and will be discussed with considered candidates individually based on their potential of hire. </span></p> </td> </tr> </tbody> </table> <table style="width:970.0px" border="0" cellspacing="0" cellpadding="0" align="left"> <tbody> <tr> <td colspan="3"> <p><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">Bayer is an Equal Opportunity Employer/Disabled/Veterans</span></p> </td> </tr> </tbody> </table> <table style="width:970.0px" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> <p style="text-align:justify;margin:0.0cm 0.0cm 0.0pt"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. </span></p> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="text-align:justify;vertical-align:top" colspan="4"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.</span></td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="text-align:justify;vertical-align:top" colspan="4"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top;width:150.0px"> </td> <td style="vertical-align:top;width:200.0px"> </td> <td style="vertical-align:top;width:150.0px"> </td> <td style="vertical-align:top"> </td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Division:</strong></span></td> <td style="vertical-align:top;width:150.0px"><span style="font-family:arial, helvetica, sans-serif"><span style="font-size:14.0px">Enabling Functions</span> <span style="font-size:14.0px"> </span></span></td> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Reference Code</strong></span></td> <td style="vertical-align:top"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">874563</span></td> <td style="vertical-align:top"> </td> </tr> <tr> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Functional Area:</strong></span></td> <td style="vertical-align:top;width:150.0px"><span style="font-family:arial, helvetica, sans-serif"><span style="font-size:14.0px">Quality</span> <span style="font-size:14.0px"><strong> </strong></span></span></td> <td style="vertical-align:top"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Location:</strong></span></td> <td style="vertical-align:top"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">Philippines : National Capital : Taguig</span></td> <td> </td> </tr> <tr> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Employment Type:</strong></span></td> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">Regular </span></td> <td style="vertical-align:top;width:150.0px"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif"><strong>Position Grade:</strong></span></td> <td style="vertical-align:top"><span style="font-size:14.0px;font-family:arial, helvetica, sans-serif">E11</span></td> <td style="vertical-align:top"> </td> </tr> </tbody> </table>