Work Location , Expected Annual Income :
Tokyo,10.0M ～ 13.0M
About the Company :
Global Rare Disease Pharmaceutical Company, Small Sized
Responsibilities :
- Act as the local quality assurance/quality system representativ
- Establish and maintain Affiliate Quality Management System (QMS) and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements.
- Conduct local supplier assessment and oversight including QTAs maintenance and local audits conduct.
- Control and supervise the reception, repacking, testing, product release, warehousing and distribution of our company's products by the local third parties from the quality viewpoint.
- Ensure management of the distribution activity, being responsible for local Authorities and maintain contact for distribution issues from the quality viewpoint.
- Drive remediation plan when a product quality or GxP process issue is identified.
- Set up comprehensive training program and perform training for relevant GxP members regarding Affiliate QMS implementation.
- Implement and manage Change Control systems/activities and Product Complaints systems/activities.
- Assure Deviation management including temperature excursion and CAPA management.
- Assist Crises Management Teams as local Product Recall Lead in the case of Product Recall.
- Ensure the Affiliate self-inspection, audit readiness and business continuity systems and activities are in place and implemented to cover GxP processes.
- Conduct mock-recalls and Act as the Affiliate Product Recall Lead when the situation arises.
- Ensure Quality Management Review and KPIs are established.
- Assist distributors complying with the guidelines of Good Distribution Practices (in particular cold chain and transportation).
- Support, oversee and manage any local analytical product release activities (Analytical transfers; Protocol and Report reviews; facilitate troubleshooting; support any OOS; Product release, if applicable).
- Develop relationship and closely work with Global Quality, Affiliate Quality Managers and Partner Quality managers.
- Act as Quality interface for local distribution partners.
Benefits :
Employment Type: Full time employee (正社員)
Office Location: Central Tokyo, Japan
Working Model: Hybrid, 2-3 days in office with flex time.
Interviews: 3
Budget: Up to 13 Mil (base+bonus)
Welfare and Insurances: Covered
Required Experience / Abilities / Skills :
Education / Certifications (essential):
- Bachelor’s Degree in Pharmaceutical Sciences (or another scientific discipline)
Education / Certifications (preferred):
- Master’s Degree in Pharmaceutical Sciences (or another scientific discipline)
Knowledge & Experience (essential):
- Proven experience in Quality Assurance and/or Quality Management Systems
- Thorough knowledge of local regulatory requirements
- Experience in writing and implementing SOPs is essential
Knowledge & Experience (preferred):
Experience in working at both MAH HQs and GMP manufacturers
Language(s) (essential):
- Fluent Japanese
- English (business level)