Johnson & Johnson Careers

【Vision/ AMO】Quality Assurance Associate Manager

Chiyoda, Japan
Quality Assurance

Job Description

Requisition ID: 1905761683W

Reporting to the Manager of Quality Assurance, associate manager serves as a Quality Assurance resource dedicated to marketing authorization holder of medical devices, pharmaceuticals and quasi-drugs. The role is to ensuring compliance to GxP for quality control, manufacturing control and distribution operations performed at marketing authorization holder, manufacturing sites and suppliers.

•Establish and maintain the procedures for operations where QM has functional responsibilities to ensure the processes are efficient and in compliant to QMS/GQP ordinance and other applicable regulations and standards as well as global standards.
•Conduct internal and supplier audit.
•Participle in the preparation and conclusion of quality agreement and liaison with manufacturing sites and suppliers.
•Support or manage deviations, change control, and corrective and preventative action plans (CAPA) at marketing company and at manufacturing sites and materials suppliers.
•Support successful new product launch from local regulatory/ quality /customer requirement perspective. (such as risk management file creation, local labeling creation and document (seihinhyojunsyo/ hinshitsuhyojunsyo) creation
•Market release for Drugs and Quasi-Drugs
•Apply QMS/GMP Compliance Inspection
•Monitor changes and execute necessary actions
•Support to correspond to external and internal inspections as an MAH
•Support field action activities as an MAH

•Bachelor or master degree in science or engineering with 3 or more years’ experience in the pharmaceutical and/or medical device industry working. 
•Experience and background in manufacturing, QA/QC, auditing or preparation and conclusion of contract is highly desirable.
•Solid knowledge and training in QMS/GxP, QA and Japanese Regulations, awareness of ISO13485, 9001 and 14971
•Good verbal communication and ability to keep excellent working relationships with peers and management.
•Fluency in English-both Written/Verbal (TOEIC 700 or above)

•Ability to handle multiple tasks
•Problem solving skill
•Self-starter /driven
•Word, Excel

Primary Location
Johnson & Johnson K.K. (8235)
Job Function
Quality Assurance
Requisition ID