Quality Assurance Auditor

PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

SCOPE OF RESPONSIBILITIES

1. Communication

• 1.1. Serves as the communication point to project teams with regard to quality assurance (QA) study audits
• 1.2. Follows up with project teams with regard to resolution of PSI QA study audits
• 1.3. Liaises with PSI divisions/operational offices with regard to internal systems, process, and location audits
• 1.4. Liaises with vendors with regard to vendor qualification audits
• 1.5. Serves as the communication point for PSI Operations staff with regard to issues related to quality assurance
• 1.6. Serves as the communication point for PSI clients with regard to QA audits contracted to PSI

1. Planning and scheduling

• 2.1. Prepares, conducts, and reports QA study audits
• 2.2. Assembles QA study audits documentation
• 2.3. Takes part in the preparation, conduct, and reporting of internal systems audits
• 2.4. Takes part in the preparation, conduct, and reporting of internal locations audits
• 2.5. Takes part in the preparation, conduct, and reporting of vendor qualification audits
• 2.6. Takes part in the preparation, conduct, and reporting of internal process audits

1. Training

• 3.1. Trains PSI Operations staff in quality management topics

1. Bachelor or above degree in life science or an equivalent combination of education
2. Minimum of 3 years in quality management or quality assurance, 2 to 3 supervised QA audits is a must
3. Full working proficiency in English and Japanese
4. Communication, presentation, and customer-service skills
5. Team building, leadership and organizational skills
6. Proficiency in MS Office applications, including MS Project

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