The position plays a critical role in ensuring GMP compliance, maintaining pharmaceutical quality, and ensuring stable supply aligned with global standards and Japanese regulatory requirements. It involves leading quality assurance efforts, collaborating with management, and maintaining high ethical and quality standards to improve patient care.
業務内容:
Develop and manage Quality Management Systems (QMS)
Handle inspections and self-audits
Manage GMP compliance surveys
Oversee CAPA management
Maintain and improve data integrity
Collaborate with related departments and lead projects
Acquire and apply knowledge of local regulations and global standards
応募資格:
5 years or more of experience in pharmaceutical manufacturing or related quality assurance roles
Knowledge of Pharmaceutical Affairs Law, GMP, PIC/S, ICH, etc.
Knowledge and experience in GMP audits
Strong communication abilities with relevant departments
Leadership and problem-solving skills
Adaptability and flexibility to change
Business-level English proficiency (TOEIC 750 or higher)
Project management experience (preferred)
Bachelor’s degree or higher in pharmacy or related science fields
Excellent communication skills with stakeholders
歓迎条件:
Project management experience
Experience leading projects
Oncology experience
待遇:
Health insurance
Employee pension insurance
Employment insurance
Annual bonuses
Paid holidays including weekends and public holidays
