Clinical Trials Quality Assurance Auditor

hace 2 días

Buenos Aires, Argentina PSI CRO A tiempo completo
Job Title: Clinical Trials Quality Assurance Auditor

We are seeking a highly skilled Clinical Trials Quality Assurance Auditor to join our team at PSI CRO. As a Clinical Trials Quality Assurance Auditor, you will play a critical role in ensuring the high quality of our clinical trials and internal company processes.

Key Responsibilities:

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

Requirements:

  • MD, PharmD, or degree in life sciences is a plus.
  • A minimum of 3 years' experience in quality management or quality assurance in a 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.

What We Offer:

At PSI CRO, we are committed to investing in our people and their professional development and success. Our recruitment process is easy and straightforward, and we will guide and support you every step of the way. We will provide you with the information you need to make an informed decision about your career.

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