Clinical Trials Quality Assurance Auditor

hace 2 semanas


Ciudad de México, Ciudad de México PSI CRO A tiempo completo

We are seeking a Quality Assurance Auditor to join our international team, working across multiple locations and time zones. This role is home-based in Mexico.

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.

Key qualifications include:

  • MD, PharmD or degree in life sciences is a plus
  • A minimum of 3 years' experience in quality management or quality assurance in clinical study environment
  • Must have experience in planning, conducting and reporting of QA audits
  • Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
  • Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
  • Excellent time management skills
  • Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to travel

At PSI CRO, we focus on our people and invest in their professional development and success. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way.



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