Quality Assurance Auditor II
Parexel
Taipei, Taiwan
11天前

Job Purpose : The Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, PAREXEL procedures and appropriate PAREXEL processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision.

Provide advice on regulatory compliance, with appropriate supervision.Specialized Area : Billable Audits & Client Relationships : Ensure audits are performed to a high degree of client satisfaction and within the budgeted time Ensure required audits are delivered in accordance with clients requirements and PAREXEL / Sponsor procedures as applicable Ensure that systematic issues raised during billable audits are escalated to QA Lead Develop and optimize new and existing processes to maintain and improve quality within the billable group.

Plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and PAREXEL / Sponsor procedures, independently or with minimal supervision.

Perform and deliver high quality audits / audit reports within specified timelines / budgets, with oversight. Lead or participate in co-

audits / observed audits with client representatives or other QA auditors. Travel internationally for audits as required.

Follow-up auditsCollect and review responses to audit observations and follow-up / escalateinadequate or delayed responses as necessary to ensure timelines are metand responses of satisfactory quality are obtained.

Support auditor trainingAssist with the training of new / less experienced auditors by performing coaudits,delivering training, and sharing knowledge and experience.

Maintain records / systemsMaintain required QA tools and ensure PAREXEL and QA systems areregularly updated with accurate information for audits and other activities.

Provide consultancyProvide advice on regulatory compliance to clients, PAREXEL Operationsand PAREXEL Quality. Support the development, maintenance, review andimprovement of PAREXEL procedures, systems and tools by providingconstructive ideas and suggestions.

  • Support the Sponsor Auditand Inspection TeamFacilitate sponsor audits / regulatory inspections, as assignedFosters a good working relationship with internal and external clientsPromote compliance withinPAREXELWorking knowledge and expertise of PAREXEL policies, procedures, andguidelines, as well as applicable national and international regulations andrequirements;
  • able to apply them as neededProactively recognize areas for process / procedural improvements,providing input to management and taking the initiative, as appropriate

    Qualifications

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