Quality Assurance Auditor Lead

hace 3 días

Buenos Aires, Buenos Aires C.F., Argentina PSI A tiempo completo

Job Overview

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We are seeking an experienced Quality Assurance Auditor to join our international team as a key member in ensuring high-quality standards within our clinical trials and internal company processes.

The successful candidate will be responsible for conducting audits, communicating with project teams, and training PSI Operations staff on quality management topics. This is an excellent opportunity to gain exposure to all aspects of the clinical trial process across multiple therapeutic areas.

Your Key Responsibilities:

  • Conduct QA study audits, internal systems and location audits, vendor qualification audits, and maintain relevant communication with the auditee.
  • Communicate with project teams regarding QA study audits, including follow-up and resolution.
  • Assemble QA audit documentation.
  • Train PSI Operations staff in quality management topics.

Requirements:

  • MD, PharmD or degree in life sciences preferred.
  • 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.

Compensation and Benefits:

The estimated salary range for this position is $80,000-$120,000 per annum, commensurate with experience. In addition to competitive compensation, we offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

About Us:

PSI is a dynamic company that focuses on its people and invests 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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