06 ago
|
IRE
|
Ciudad de México
06 ago
IRE
Ciudad de México
Senior Auditor, Quality Assurance
ICON is a integral healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking a Senior Auditor, Quality Assurance to join our diverse and dynamic team. As a Senior Auditor, Quality Assurance 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.
What you will be doing
- Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
- Contributing to inspection readiness and participating in health authority inspections as needed.
- Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
- Providing expert guidance and practical recommendations to stakeholders regarding GCP and quality assurance best practices.
- Identifying areas for improvement and contributing to the continuous enhancement of QA programs and initiatives.
Your profile
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field, or equivalent relevant experience.
- Minimum of 5 years of experience in quality assurance, auditing, or inspections within the pharmaceutical, biotechnology, or CRO industry.
- Proven experience with GCP’s (Good Clinical Practices), site audits, and clinical quality oversight. (NOT other GxP’s)
- Strong understanding of regulatory requirements and quality systems related to clinical research.
- Analytical mindset with excellent problem-solving abilities and attention to detail.
- Effective communication and interpersonal skills, with the ability t
📌 Senior Auditor, Quality Assurance (Ciudad de México)
🏢 IRE
📍 Ciudad de México