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 role**:
Our Quality Assurance Auditor role is opened within our Compliance team team and will focus on CAPA management, inspection support.
The responsibilities will include:
- Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues.
- External audits/inspections findings ensuring responses/CAPA are in line with ICON SOPs and submitted within the require timelines.
- Ensure that the ICON's QMS/ tracking system is updated with the appropriate information and documentation.
- Follow-up of CAPA plans to ensure actions are completed on time and the evidences available are adequate.
- Perform the assessment of the potential Quality Issues to determine whether they meet the requirements of an ICON Quality Issue, document the outcome and record the Quality Issues as requested.
- Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly.
- Assist Q&C Management / Director with oversight of open CAPAs, trending and analysis of CAPAs and metrics reporting.
This includes providing summary information/input to Governance reports.
- *Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.
- Ensure that any case types including suspected scientific misconduct, risk cases and potential serious breach is tracked and documented as requested.
- Liaise with clients and regulatory authorities as needed
**Benefits of Working in ICON**:
Our success depends on the quality of our people.
That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages.
And to keep them competitive, we regularly benchmark them against our competitors.
Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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.
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