Require QA Senior Auditor at ICON plc

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.

Post : Senior Auditor, Quality Assurance

Seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies.

Job Description
• Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans.
• Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.
• Lead/Support regulatory Inspection hosting
• Lead/Support Sponsor Audit Hosting
• Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management
• Manage Quality Issues
• Lead Quality Issue Investigations
• Supports Operations in Root Cause Analysis and CAPA Plan preparation.
• Support Effectiveness Check development and outcomes.
• Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
• Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations.
• Mentor new or developing Q&C staff as assigned.
• Support business development activities and Q&C initiatives as needed.
• Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host
• Host Sponsor audit ICON as Lead Host or Co-host

Candidate Profile
• 5 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry.
• Advanced knowledge of GCP (Good Clinical Practice)
• Excellent organizational skills.
• Must possess a technical knowledge that is applicable to clinical drug development.
• An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required
• Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
• Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
• Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
• Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision
• Read, write and speak fluent English.

Additional Information
Experience : 5 years
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Job ID : JR128238
End Date : 30th June 2025