Quality Assurance Auditor at PSI CRO

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Study Auditing, Vendor Qualification, Internal Systems Auditing, Quality Management, English Proficiency, Japanese Proficiency, Communication Skills, Presentation Skills, Customer Service, Team Building, Leadership, Organizational Skills, MS Office, MS Project

Industry

Pharmaceutical Manufacturing

Description

Company Description 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. Job Description 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 Qualifications 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 Additional Information Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Responsibilities

The role involves preparing, conducting, and reporting on QA study, system, location, and vendor audits. Additionally, the auditor serves as the primary communication point for project teams, clients, and vendors regarding quality assurance issues.