Senior QA Auditor

Senior QA Auditor

Location: Dublin 18, Ireland

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business but that doesn't mean we can't have fun whilst we do it.

With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry!

Are you one of them?

At ICON, we have an incredible opportunity for an expert Senior QA Auditor to join the team in our Global HQ in Dublin, Ireland.

ICON's Quality Assurance team provides support to all clinical sides of our business. Working on complex QA matters across the business, the QA team delivers on projects for ICON and our clients.

This role will include post COVID travel of up to 35%.

The Role

• Leading on external audits and inspections of ICON including scheduling, preparation and hosting.
• Supporting inspection readiness activities, including inspections of ICON and/or investigator sites.
• To lead CAPA management for external audits of ICON and regulatory inspections of ICON and/or investigator sites, where needed, in order 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.
• Preparing root cause analysis on quality issues including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs.
• Manage 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.
• 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 critical CAPA initiatives and effectiveness check audits, as needed

What you need

• 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.
• Experience in hosting external audits and/or regulatory inspections
• Knowledge of CAPA management, including performing effective root cause analysis
• Experience in regulatory authority inspections an advantage
• Knowledge of 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.

Why join us?

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Senior QA Auditor, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin