My client is an international biopharmaceutical company that has more than 60k employees globally and more than 3k employees in Japan, focusing on developing and manufacturing drugs/vaccines for critical diseases.
- Role: Quality Assurance Specialist
Location: Maibara, Shiga, Japan (Relocation package available)
Requirement:
- 2-3 years of experience in the pharmaceutical industry
- Knowledge of manufacturing management and quality control in GMP/GQP/QMS
- Fluent in English
Responsibilities:
- Judgment of product shipment in accordance with domestic GMP standards, management of manufacturing sites, investigation of deviations, planning of recurrence prevention, and investigation of quality information (complaints from the market)
- Improve the standard of the quality assurance work
- Improve product quality through communication with overseas manufacturing sites
- Role: Regulatory Lead - Japan
Location: Osaka or Tokyo, Japan (Relocation package available)
Requirement:
- Bachelor's Degree in Science or related discipline
- 5-7 years of experience in Regulatory Affairs or in the Pharmaceutical industry
- Knowledge in drug development
- Experience in cross-functional project
- Drug development and regulatory affairs experience in foreign markets would be a plus
- Fluent in English
Responsibilities:
- Developing Japan regulatory strategy for the company's products or projects
- Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input is properly understood by the governance bodies in GMeds, iMeds, and MedI for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
- Managing quality regulatory deliverables of the assigned products/projects throughout the product's lifecycle
For further information about this position please apply.
