QA Auditor II
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
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.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Spain, United Kingdom, France
Department
Project Management Roles
Location
France
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109611
Expiry date
01/01/0001
Author
Tanzina GuerniAuthor
Tanzina GuerniSalary
Location
Turkey
Department
Clinical Monitoring
Location
Turkey
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-108618
Expiry date
01/01/0001
Salary
Location
Netherlands, Assen (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Assen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Program Management
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117776
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Poland, Warsaw
Location
Sofia
Warsaw
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
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, biotech
Reference
JR116887
Expiry date
01/01/0001
Author
Hajni HowardAuthor
Hajni HowardSalary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Procurement
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR114855
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Netherlands, Amsterdam, Schiphol
Location
Amsterdam
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
JR119275
Expiry date
01/01/0001
Author
Rajkapoor KamaludeenAuthor
Rajkapoor Kamaludeen