Clinical Trials Quality Assurance Specialist

hace 2 semanas


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

Job Description


We are seeking a skilled Quality Assurance Auditor to join our team at PSI, where you will play a vital role in ensuring high quality standards within our clinical trials and internal company processes.


Key Responsibilities



  • Develop and implement QA study audits, internal systems and location audits, and vendor qualification audits
  • Collaborate with project teams to ensure effective QA study audits, including follow-up and resolution
  • Maintain accurate and comprehensive QA audit documentation
  • Provide training and support to PSI Operations staff on quality management topics

Requirements



  • MD, PharmD or degree in life sciences is a plus
  • Minimum 3 years' experience in quality management or quality assurance in a clinical study environment
  • Proven expertise in planning, conducting and reporting of QA audits
  • Strong knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
  • Excellent communication and interpersonal skills, with a proactive attitude to tasks and projects
  • Ability to manage time effectively and meet tight deadlines
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to travel

About PSI


At PSI, we invest in our people's professional development and success. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way. We guide and support you throughout the process, making your experience as smooth as possible.



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