GxP Audit Services Expert

PURPOSE

• Provide administrative support to the Quality Audits & Inspections internal auditors team.
• 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)

YOUR TASK AND RESPONSIBILITIES

• 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)).
• Arrange pre-audit preparation (pre-meeting participants identification, dates alignment, invitations distribution, audit announcement, and others as aligned with the APM).
• Enter draft audit report in IQMS (audit details, reporting & summary, distribution lists completion, audit elements, observations)
• 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)
• Process minor corrections in draft audit report after the auditee revision (typographical errors, incorrect dates, changes in SOP numbers).
• 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)
• Corrective and Preventive Action Plan (CAPA) maintenance (follow-up with auditees, monitoring, reporting, and closure of minor observations as advised by the APM).
• 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)
• Ensures timely compliance with the Service Level Agreement
• Perform quality reviews of GxP AS Critical Activities; act as the main reviewer
• Maintenance of Quality, Audit and Inspection Process controls
• Stakeholder Management: Issue resolution, Initiate clarification discussions
• Monitor team status and SLAs
• Regular reporting/alignment and escalation of any issues to Senior Expert and Lead, if necessary.
• Perform the regular review of QAI systems and processes including desktop procedures for compliance with the applicable stakeholder regulations
• Drive continuous process improvement for GBS Quality Audit Inspection stakeholders and internal initiatives
• Support internal and/or external audits or inspection when needed.

WHO YOU ARE

• Professional experience (at least 3 years) in related fields.
• Administrative assistant experience highly appreciated.
• Familiar with the concept of KPIs. Experience working with KPIs is not mandatory but highly appreciated.
• Audit experience preferable but not mandatory.
• Experience with Veeva IQMS, not mandatory but highly appreciated.
• Ability to operate in a highly intercultural environment
• Communication skills. English language skills mandatory, any other language beneficial.
• Accuracy and organizational skills.
• Strong attention to detail
• Strong Customer Focus
• Strong Communication and Collaboration Skills
• Good Stakeholder Management
• Drives results
• Manages Complexity