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

2. 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

3. 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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