Job Summary:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Senior Auditor, Quality Assurance to join their team. This remote position based in India focuses on maintaining and improving the Quality Management System, supporting regulatory inspections, and ensuring clinical trial compliance with industry standards such as GCP. This role is ideal for candidates with strong auditing experience and a background in clinical or regulatory environments.
Key Responsibilities:
Manage complex quality issues including root cause analysis, impact assessments, and CAPA plans.
Lead and support regulatory inspection and sponsor audit hosting activities.
Independently manage quality issue investigations and lead effectiveness checks.
Assist in maintaining and improving the Quality Management System.
Train and mentor new Quality & Compliance (Q&C) staff.
Provide operational support for root cause analysis and CAPA plan development.
Host site, ICON, and sponsor regulatory inspections and audits.
Contribute to business development and Q&C initiatives as needed.
Required Skills & Qualifications:
Minimum 5 years of experience in clinical, regulatory, pharmacovigilance, or quality functions within CRO, pharmaceutical, or healthcare sectors.
In-depth knowledge of Good Clinical Practice (GCP) guidelines.
Bachelor’s degree in science, technology, auditing, or related fields (international equivalents accepted); sufficient auditing experience also considered.
Strong understanding of clinical drug development processes.
Proficiency in MS Office tools (Word, PowerPoint, Excel).
Excellent analytical, critical thinking, and communication skills.
Ability to manage complex scenarios and influence teams for achieving quality goals.
Fluent in spoken and written English.
Perks & Benefits:
Competitive salary package (exact range not specified).
Various annual leave entitlements.
Comprehensive health insurance options.
Attractive retirement planning and savings schemes.
Global Employee Assistance Program (LifeWorks) for 24/7 wellbeing support.
Life assurance coverage.
Flexible, country-specific optional benefits (gym membership, childcare vouchers, health assessments, etc.).
Company Description:
ICON plc is a world-renowned clinical research and healthcare data solutions provider serving the pharmaceutical, biotechnology, and medical device industries. ICON focuses on delivering high-quality research services while fostering innovation and diversity in its workforce.
Work Mode:
Remote (India)
Call to Action:
Ready to make an impact in clinical quality assurance? Apply now to join ICON plc as a Senior Auditor and help shape the future of clinical development worldwide.
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