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JOB TITLE: QA Auditor II, Clinical Quality Assurance (CQA)

REPORTS TO: Manager, Governance, Risk & Compliance (GRC)

LOCATION: EU ( ICON OFFICE LOCATIONS )

POSITION SUMMARY

Lead/support external audits and inspections of ICON including scheduling, preparation and hosting.

Lead/support inspection readiness activities, including inspections of ICON and/or investigator sites.
Lead/support CAPA management for external audits of ICON and regulatory inspections of ICON and/or investigator sites, to assure responses are compliant with ICON or Sponsor SOP requirements, Good Clinical Practice guidelines and relevant regulations. Including ensuring appropriate corrective and preventative actions are put in place and CAPAs are followed until resolution.
To Lead/support Quality Issues (non-conformance / potential NC and complaints), including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs.

JOB FUNCTIONS/RESPONSIBILITIES

Lead/support inspection readiness activities, including inspections of ICON and/or investigator sites.
Lead CAPA management for inspection of ICON and /or investigator sites, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution.
Lead CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up.
Lead / support quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
Ensure that CAPAs are formally recorded and reported and that corrective/preventive actions are documented and followed until resolution.
Identify and track required effectiveness checks and ensure effectiveness checks are completed within the require timelines.
Provide advise and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
Lead / support critical CAPA initiatives, as needed
Support / lead effectiveness check audits, as needed
Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.
Travel (approximately 35%) domestic and/or international

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Background in medicine, science and/or other relevant discipline and appropriate experience.
Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
Knowledge/ experience in hosting external audits and/or regulatory inspections
Knowledge / experience in CAPA management, including performing effective root cause analysis
Knowledge / experience in regulatory authority inspections an advantage
Knowledge / experience in medical Device (MDDR) an advantage
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 at least 35% of the time (international and domestic).

EDUCATION REQUIREMENTS:

University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience

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QA Auditor II

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