Senior QA Auditor - Client Audit Management
Location options :
Dublin (Office based) or
European Regional base locations (Office based, or Remote options available depending on location)
The opportunity :
The Audit Defense team are seeking an individual to join them on a Secondment basis to cover maternity leave within a Senior Auditor position.
This is a great opportunity for someone with a clinical background to develop their career within Quality Assurance.
This is a specialized team responsible for leading client audits of ICON globally for our clinical, PV and technology services.
The team work directly with the client auditors to arrange, prepare for and host the external audit, liaising with the internal ICON team to ensure the client audit expectations are met and that the audit is a success.
The team also manage any resulting observations and CAPAs which ensures the external auditor has one central point of contact for the duration of the audit through to closure.
The Audit Defense team have many years' experience of hosting both on-site audits conducted at ICON facility, as well as hosting remote audits using technology available to ensure the audit scope can still be met remotely.
Key responsibilities will include :
Leading and supporting external audits of ICON including scheduling, preparation and hosting.
Leading CAPA management for external audits of ICON and / or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements
Leading 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.
Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
Ensuring 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.
Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and / or vendors, when deemed necessary.
To be successful in the role, you will have :
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 the client.
Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.
Hiring manager : Christophe Baduel
Recruiter : Becky Parsons