QA Auditor I

QA Auditor I,

Quality Governance Risk & Compliance

China

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.

Job Title: QA Auditor I, Governance Risk and Compliance

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

ü AUDIT DEFENSE Responsibilities:  

• Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of ICON including;

-    Host  Sponsor or  Regulatory onsite or remote  audits/inspections such  as  leading/co-leading opening and close out meeting activities, processing document & information requests, supporting operational  targets  in  audit  defense  activities,  leading  audit/inspection  support activities/ preparation work streams, escalating potential issues,  and providing audit summaries to senior management, as needed

-    Follow-up activities including provision of outstanding requests, handover to the CAPA Lead.  

• Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of Investigational Sites including:

- Preparation activities such as liaising with the Sponsor; identifying, escalating and mitigating any risks with the appropriate ICON management; preparing operational teams and investigational site staff, as needed

- Support ICON and Sponsor operational teams during the audit/inspection conduct including review & processing any ICON document requests; liaising with the Sponsor under guidance of his/her line manager; finalizing and distributing daily summaries and attending the inspection on site as needed

- Follow-up  activities,  including  liaising  with  the  Sponsor  and/or  regulatory  inspectors  (under guidance of his/her line managers) and handover activities to the assigned CAPA Lead.

ü CAPA MANAGEMENT:  

•Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPA management including

- Lead RCA and investigation meetings with relevant operational responsible persons, 

- Liaise with the client, providing input on CAPA plans and

- Ensure ICON’s QMS/ tracking system updated with the appropriate information and documentation

•Lead CAPA management for internal & external audits & inspections including:

- RCA and investigation meetings with relevant operational responsible persons,

- Liaise with the Sponsor and/or Regulator

- Provide input on CAPA plans

- Ensure   ICON’s   QMS/ tracking   system   updated   with   the   appropriate   information   and documentation.    

• 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;

ü More than 3 year experience in the clinical research filed, working as a CRA, Study Start-up Associate, Project Manager, etc.

ü A bachelor’s degree in a science or medical area. Ideally you’ll have a master’s degree that focuses on clinical research;

ü The ability to communicate well, an understanding of compliance as well as the confidence to obtain funding;

ü Good command of written and spoken English;

ü Computer-literacy;

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

Additionally, we have cutting edge technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance. 

If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com