Quality Assurance Specialist

hace 6 días

Xico, México Icon Plc A tiempo completo
Senior Auditor, Quality Assurance

A challenging opportunity has arisen for a highly skilled Senior Auditor, Quality Assurance to join our team at ICON Plc.

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

Key Responsibilities:

  • Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans.
  • Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.
  • Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:
    • Manage Quality Issues
    • Lead Quality Issue Investigations
    • SUPPORTS Operations in Root Cause Analysis and CAPA Plan preparation.
    • Support Effectiveness Check development and outcomes.
    • Manage CAPAs resulting from Sponsor Audits, Inspections and/or Internal Audits.
    • Assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
    • Perform departmental and ICON staff training regarding ICON's quality system, Q&C tasks and processes, applicable standards, and regulations.
    • Mentor new or developing Q&C staff as assigned.
    • Support business development activities and Q&C initiatives as needed.

Requirements:

  • 3-6 years' experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
  • Advanced knowledge of GCP (Good Clinical Practice).
  • Excellent organizational skills.
  • Excellent knowledge of internal auditing standards.
  • Must possess a technical knowledge that is applicable to clinical drug development.
  • An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
  • Extensive experience in investigator site, vendor, and process audits.
  • Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
  • Experience working in a quality assurance role within an internal audit function (preferred).
  • Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision.
  • Read, write and speak fluent English.

What ICON can offer you:

  • A competitive salary range of $80,000 - $120,000 per year, depending on experience.
  • A range of additional benefits, including various annual leave entitlements, health insurance offerings, retirement planning options, and more.

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