Senior Quality Assurance Auditor

hace 20 horas


Xico, México Icon Plc A tiempo completo

Job Summary

Icon Plc is seeking a highly skilled Senior QA Auditor to join our Inspection Management team. As a Senior QA Auditor, you will play a critical role in supporting regulatory inspection activities and leading client audits of our clinical, PV, and technology services.

Key Responsibilities

  • Lead and support regulatory inspection activities, including preparation and hosting, to ensure seamless execution and client satisfaction.
  • Liaise with internal teams and clients to support inspection readiness activities, ensuring timely completion of audit responses and compliance with regulatory requirements.
  • Manage CAPA (Corrective and Preventive Action) processes for regulatory inspections and external audits, ensuring effective implementation of corrective and preventative actions.
  • Investigate quality issues, perform root cause analysis, and implement adequate corrective and preventative actions to ensure compliance with GCP and regulatory requirements.
  • Provide guidance and support to operation teams to ensure CAPA compliance with regulatory requirements.
  • Support other Q&C teams with audits of Icon, including conducting audits of investigator sites and vendors as needed.

Requirements

To be successful in this role, you will need to have a strong clinical background, excellent communication and interpersonal skills, and the ability to work effectively in a team environment. You will also need to have a deep understanding of regulatory requirements and compliance procedures.



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