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Clinical Trials Quality Assurance Auditor

Há 1 mês


São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro

We are seeking a Quality Assurance Auditor to join our international team, working across multiple locations and time zones. This role is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

Your responsibilities will include:

  • Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
  • Communicating with project teams with regard to QA study audits, including follow-up and resolution
  • Assembling QA audits documentation
  • Training PSI Operations staff in quality management topics

Please note, this role requires international travel for site audits.

The ideal candidate will have a strong background in quality management, excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations. They will also possess excellent communication and interpersonal skills, including a proactive attitude to tasks and projects.

As a Quality Assurance Auditor, you will be responsible for ensuring high quality standards within our clinical trials and internal company processes. You will work closely with project teams to ensure that all audits are conducted in a timely and efficient manner.

We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.