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We are seeking a highly skilled Senior Auditor, Quality Assurance Specialist to join our Inspection Management team at ICON Plc. As a key member of our team, you will be responsible for leading and supporting regulatory inspection activities, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities- Regulatory Inspection Leadership: Lead and support regulatory inspection activities, including preparation, hosting, and follow-up.
- Client Liaison: Liaise with clients to arrange, prepare for, and support regulatory inspections and external audits.
- CAPA Management: Lead and manage CAPA (Corrective and Preventive Action) activities for regulatory inspections and external audits.
- Quality Issue Investigations: Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions.
- Documentation and Reporting: Ensure accurate and timely documentation and reporting of inspection activities and CAPA.
- Collaboration and Communication: Collaborate with cross-functional teams, including operations, quality, and regulatory, to ensure seamless execution of inspection activities.
- Experience: Minimum 3 years of experience in a quality assurance or regulatory inspection role.
- Knowledge and Skills: Strong knowledge of regulatory requirements, industry standards, and quality management systems.
- Communication and Interpersonal Skills: Excellent communication and interpersonal skills, with the ability to work effectively with clients, internal stakeholders, and cross-functional teams.
- Problem-Solving and Analytical Skills: Strong problem-solving and analytical skills, with the ability to investigate and resolve quality issues.
- Education: Bachelor's degree in a relevant field, such as life sciences, chemistry, or a related field.
ICON Plc is a world-leading healthcare intelligence and clinical research organization. We are committed to delivering high-quality services and solutions to our clients, while fostering a culture of innovation, excellence, and inclusivity.
What We Offer- Competitive Salary and Benefits: We offer a competitive salary and benefits package, including health insurance, retirement planning, and flexible work arrangements.
- Opportunities for Growth and Development: We offer opportunities for growth and development, including training, mentorship, and career advancement.
- Diverse and Inclusive Work Environment: We strive to create a diverse and inclusive work environment, where everyone feels valued, respected, and empowered to contribute their best work.
