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Senior Quality Assurance Auditor
hace 2 meses
At ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Senior QA Auditor to join our Inspection Management team.
About the RoleThis is a specialized team responsible for supporting regulatory inspection activities of clients, investigator sites, and ICON. As a Senior QA Auditor, you'll lead and support regulatory inspection activities, including preparation and hosting. You'll also liaise with ICON Operational Functional Leads and clients to ensure inspection readiness activities are successful.
Key Responsibilities- Lead and support regulatory inspection activities of ICON, clients, and investigator sites, including preparation and hosting.
- Liaise with ICON Operational Functional Leads and clients to support inspection readiness activities.
- Lead and support external audits of ICON, including scheduling, preparation, and hosting.
- Lead CAPA management for regulatory inspections/external audits of ICON, clients, and/or investigator sites, ensuring responses are compliant with ICON or Sponsor SOP requirements.
- Lead quality issue investigations, ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
- Ensure CAPAs are formally recorded and reported, and actions are documented and followed until resolution.
- Identify and track required effectiveness checks and ensure checks are completed within the required timelines.
- Provide advice and support to operation teams where needed to ensure CAPAs are compliant with GCP and applicable regulatory requirements.
- Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites, and/or vendors, when deemed necessary.
- Knowledge/experience in hosting external audits and/or regulatory inspections.
- Knowledge/experience in CAPA management, including performing effective root cause analysis.
- Ability to review and evaluate clinical data/records.
- Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators, and clients.
- Detailed understanding of drug development and clinical trial process.
- Good problem resolution skills.
- Good planning and organizational skills with the ability to multi-task and prioritize effectively.
- Ability to work efficiently and independently under pressure.
- Ability and willingness to travel on occasion to accommodate clients.
- Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.
- Bachelor's Degree or Equivalent Experience.
We offer a range of benefits to support your well-being and work-life balance, including various annual leave entitlements, health insurance, retirement planning, and more. We're an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.
