A global biotechnology company
This position will directly report to Quality Assurance supervisor Japan and have responsibility for leading the execution of all Quality Assurance (GQP/QMS) activities.
Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives
from Medical device and drug perspective.
Contribute to Product life cycle management in a global organization, among
global/domestic companies (change management, quality agreement, audit, quality issue handling, CAPA etc.)
Ensure full compliance with applicable regulations in Japan.
Oversee all activities or responsibilities that are delegated to external parties.
5+ years Knowledge of relevant in Quality Assurance in healthcare (pharmaceutical or medical devices) industry.
• Experience quality operations listed below in post-marketing and/or manufacturing environment.
Quality information handling such as complaint, deviation, CAPA etc
Improvement of quality processes as shown the above
Establish, revise or maintain SOPs
Inspection by authorities
Understanding of PMD Act, relevant regulations and guidelines.
Experience communication in English with business partners, ability to communicate reading, writing, and speaking in English is strongly preferred.
Bachelor's Degree in Science or related discipline