The role serves as a crucial link between R&D and Manufacturing facilities to secure the portfolio and deliver high-quality drugs and vaccines
Job Summary
The role serves as a crucial link between R&D and Manufacturing facilities to secure the portfolio and deliver high-quality drugs and vaccines.
Responsibilities include handling product technical complaints for medical devices and biologics while ensuring strict adherence to global and country-specific regulatory standards.
Candidates must be fluent in Japanese to facilitate communication for complaint handling across supported regions.
Matching Summary
The role serves as a crucial link between R&D and Manufacturing facilities to secure the portfolio and deliver high-quality drugs and vaccines.
Skills & Requirements
Must-have
Fluent Japanese language skills
Product technical complaint handling
GxP regulatory compliance knowledge
Cross-functional stakeholder collaboration
Quality Management System (QMS) record management
Nice-to-have
Strong analytical problem-solving abilities
Adaptability to dynamic environments
Continuous improvement mindset
Excellent English communication skills
Proactive identification of process improvements
Key Requirements
Bachelor's or Master's degree in Business Administration or related field
Minimum 1-2 years of professional experience in documentation
Fluency in Japanese (write, speak, read)
Proficiency in Quality DMS, Word, Excel, and PowerPoint