Remote Clinical Trials Quality Assurance Auditor

Summary

Join a tight-knit, international team at PSI as a Quality Assurance Auditor to ensure high quality standards within clinical trials and internal company processes.

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

Responsibilities

• Preparing, conducting, and reporting of QA study audits
• 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