Quality Assurance Auditor Ii

2 days ago

Chennai Tamil Nadu, India ICON Plc Full time

Quality Assurance Auditor II

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 II to join our diverse and dynamic team. As a Quality Assurance Auditor II 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 innovative treatments and therapies.

Location: Chennai ( Home-Based)

What you will be doing
- Assisting in the development and implementation of quality assurance strategies and processes to support clinical trial activities.
- Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
- Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
- Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness.
- Contributing to the continuous improvement of quality assurance practices and procedures.

Your profile
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 2 years of experience in quality assurance within the pharmaceutical, Biotechnology, or CRO industry.
- Should have knowledge of Computer System Validation (CSV) and Review of Validation documents.
- Should have experience in performing Internal & Vendor Technology Audits.
- Familiarity with regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong attention to detail and analytical skills, with the ability to identify and resolve quality issues effectively.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels.

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

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