Quality Assurance Auditor I

Quality Assurance Auditor I - Chennai/Bangalore - Remote or Hybrid working

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 on our mission to shape the future of clinical development.

We are currently seeking a Quality Assurance Auditor I to join our diverse and dynamic team. This role is part of the Tech QA team and includes supporting GxP Risk Impact Assessments and Validation Reviews. This involves reviews of ICON and vendor delivered computerised systems and technology platforms so if you have an understanding of CSV, Vendor Qualification and some experience of operational areas (e.g. IRT, Medical Imaging, Clinical Trials) then this could be the job for you!

What you will be doing

• Assisting in the development and implementation of quality assurance processes and procedures to support clinical trial activities.

• Conducting routine quality assessments and audits to ensure adherence to regulatory standards and guidelines.

• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed.

• Participating in the review and approval of documentation related to clinical trial operations and quality management systems.

• Contributing to the maintenance of quality assurance documentation and records.

Your profile

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

• Previous experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry is preferred but Nt required.

• Basic knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).

• Strong attention to detail and organizational skills, with the ability to prioritize tasks effectively.

• Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams and stakeholders.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply