Clinical Trials Quality Assurance Specialist

hace 4 semanas


Ciudad de México, Ciudad de México PSI A tiempo completo

Job Title: Quality Assurance Auditor

We are seeking a skilled Quality Assurance Auditor to join our international team, working across multiple locations and time zones. As a Quality Assurance Auditor, you will be responsible for ensuring high quality standards within our clinical trials and internal company processes.

Your Key Responsibilities:

  • 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

Requirements:

  • 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

About PSI:

At PSI, 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. We will guide and support you with information, making your experience as smooth as possible.



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