Senior QA Auditor – Q&C Inspection Management Team
- Mexico City
- Quality Assurance
- ICON Full Service & Corporate Support
- Remote
Talent Acquisition Business Partner
- Full Service Division
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well
The opportunity:
The Q&C Inspection Management Team are seeking an individual to join them as a Senior QA 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 preparing and supporting regulatory inspections of ICON, sponsors and investigator sites globally for our clinical, PV and technology services. The team work directly with the operational study teams, clients and regulatory inspectors to arrange, prepare and host regulatory inspections. The team also manages any resulting observations and CAPAs.
The Q&C Inspection Management Team has many years’ experience of hosting and supporting both on-site inspections conducted at ICON facilities, sponsor and investigator sites as well as hosting and supporting remote inspections using technology available to ensure the inspection objectives can still be met remotely.
Key responsibilities will include:
Leading and supporting regulatory inspection of ICON, sponsors and investigator sites including scheduling, preparation and hosting.
Leading CAPA management for regulatory inspections of ICON, sponsors and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements
Leading CAPA management for regulatory inspections of ICON, sponsor and/or investigator sites, 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:
At least 3 - 5 years of Knowledge/ experience in hosting external audits and/or regulatory inspections
At least 3 - 5 years Knowledge / experience in CAPA management, including performing effective root cause analysis
Ability to review and evaluate clinical data / records.
English advanced fluent (Global exposure)
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 presentation 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.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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