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.
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
internal and supplier audit.
in the preparation and conclusion of quality agreement and liaison with
manufacturing sites and suppliers.
or manage deviations, change control, and corrective and preventative action
plans (CAPA) at marketing company and at manufacturing sites and materials
successful new product launch from local regulatory/ quality /customer
requirement perspective. (such as risk management file creation, local labeling
creation and document (seihinhyojunsyo/
release for Drugs and Quasi-Drugs
QMS/GMP Compliance Inspection
changes and execute necessary actions
to correspond to external and internal inspections as an MAH
field action activities as an MAH
or master degree in science or engineering with 3 or more years’ experience in
the pharmaceutical and/or medical device industry working.
and background in manufacturing, QA/QC, auditing or preparation and conclusion
of contract is highly desirable.
knowledge and training in QMS/GxP, QA and Japanese Regulations, awareness of
ISO13485, 9001 and 14971
verbal communication and ability to keep excellent working relationships with
peers and management.
in English-both Written/Verbal (TOEIC 700 or above)
to handle multiple tasks
Johnson & Johnson K.K. (8235)Job Function
Quality AssuranceRequisition ID