Quality Assurance Auditor
- Permanent
This role is perfect if you have clinical research experience and want to apply it differently or if you're experienced in auditing and want to explore a new field.
As a Quality Assurance Auditor, you'll be part of our friendly QA team, working closely with other QA experts. Your contributions will strengthen our Quality Management System through internal audits across various operational teams. You'll also play a key role in vendor qualification, conducting assessments to ensure vendors meet GxP standards and regulatory requirements.
Vacancy information
Your main tasks include:
- Planning, conducting, and reporting on internal audits to ensure compliance with protocols, contracts, GxP, SOPs, and regulations. This includes system, project, computerized system validation, and ISO27001 audits.
- Planning, conducting, and reporting on vendor assessments to assess vendor suitability and compliance. These vendor assessments include vendor questionnaires and vendor audits, which can be onsite or remote. Via the vendor qualification process you will encounter a wide variety of vendors, ranging from courier services, over different (specialty) labs, to storage facilities and SaaS providers.
- Participating in the yearly vendor evaluation. • Engaging in team initiatives, including training development, quality awareness, process improvements, and more. • Potentially conducting client-requested contract audits and providing expertise on various topics.
Requirements information
Your Profile:
- University degree in sciences, (para)medical area, or pharmaceutical sciences.
- Minimum 2 years of clinical research or auditing experience.
- Quality management system experience in a GxP environment is a plus.
- Fluent in English; Dutch knowledge is advantageous.
- Strong analytical, organizational, and teamwork skills.
- Familiarity with international clinical research guidelines and regulations.
