This is an exciting opportunity to join ICON.
Are you ready to be a part of a fast growing winning team? ICON's award-winning study execution capabilities have led to the approval of 18 of the world's top 20 best-selling drugs. Make your experience count for the benefit of patients worldwide.
Governance Risk & Compliance QA Auditor
China / Taiwan
ICON Governance Risk and compliance(GRC) are responsible for management of sponsor audits and inspectors of ICON. You will be responsible for operations with completion of resulting CAPAs and management of quality issues. In addition you will be supporting Clinical QA Team for management of sponsor audits and inspections in the APAC region.
Responsibilities
[AUDIT DEFENSE Responsibilities ]
* Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of ICON
* Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of Investigational Sites
[CAPA MANAGEMENT ]
*Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPA management including
*Lead CAPA management for internal & external audits & inspections
* Assist with the tracking of incoming QIs and QI triage and assessment process.
* Determine effectiveness check requirements for responsible CAPA, track and complete effectiveness checks as required
* Assist with the review of effectiveness check requirements, effectiveness check plans and effectiveness check outcomes
To be successful, you will have;
* More than 3 year experience in the clinical research filed, working as a CRA, Study Start-up Associate, Project Manager, etc.
* Previous experience in quality and compliance management to meet GCP requirements is a plus
* A bachelor's degree in a science or medical area. Ideally you'll have a master's degree that focuses on clinical research;
* The ability to communicate well, an understanding of compliance as well as the confidence to obtain funding;
* Good command of written and spoken English;
* Computer-literacy;
Benefits of Working in ICON :
Other than working with a great team of smart and energetic 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.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.