Quality Assurance Auditor

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

Your responsibilities will include:

• 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

Please note, this role requires international travel for site audits.

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