Are you passionate about ensuring quality and compliance in clinical research? ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Quality Assurance Auditor II to join their dynamic team in Chennai. This home-based role offers an exciting opportunity to contribute to groundbreaking clinical trials, ensuring adherence to regulatory standards while advancing innovative treatments. If you have experience in quality assurance, computer system validation (CSV), and a keen eye for detail, this position could be your next career move. Read on to explore the responsibilities, qualifications, benefits, and how to apply for this rewarding role.
Key Responsibilities
As a Quality Assurance Auditor II at ICON, you will play a critical role in maintaining the integrity of clinical trials. Your primary duties will include:
- Developing QA Strategies: Assist in creating and implementing quality assurance strategies to support clinical trial activities, ensuring compliance with global standards.
- Conducting Audits: Perform comprehensive quality assessments and audits, including internal and vendor technology audits, to ensure adherence to regulatory guidelines such as ICH-GCP and FDA regulations.
- Collaborating with Teams: Work closely with cross-functional teams to identify quality issues, implement corrective actions, and drive continuous improvement.
- Reviewing Documentation: Review and approve clinical trial documentation and data to ensure accuracy, completeness, and compliance.
- Enhancing Processes: Contribute to the ongoing improvement of quality assurance practices, including expertise in computer system validation (CSV) and validation document reviews.
Qualifications
To excel in this role, candidates should possess the following qualifications:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field; an advanced degree is preferred.
- Experience: Minimum of 2 years in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with specific experience in performing internal and vendor technology audits.
- Technical Skills: Strong knowledge of computer system validation (CSV) and review of validation documents.
- Regulatory Knowledge: Familiarity with regulatory requirements, including ICH-GCP and FDA regulations.
- Soft Skills: Exceptional attention to detail, analytical skills, and the ability to collaborate effectively with diverse teams.
- Communication: Excellent interpersonal and communication skills to work with colleagues and stakeholders at all levels.
Benefits of Working at ICON
ICON is committed to fostering a diverse and inclusive workplace that rewards high performance and nurtures talent. By joining the team, you’ll enjoy:
- Competitive Salary: A rewarding compensation package tailored to your experience.
- Health and Wellness: A range of health insurance plans to meet your family’s needs.
- Retirement Planning: Competitive offerings to help you save and plan for the future.
- Work-Life Balance: Generous annual leave entitlements and flexible, home-based work options.
- Global Support: Access to the Global Employee Assistance Programme (TELUS Health) for 24/7 professional support.
- Additional Perks: Flexible, country-specific benefits such as childcare vouchers, discounted gym memberships, and health assessments.
How to Apply
