QA specialist , Bio-Pharmaceuticals , Tokyo, 7M JPY
Tokyo 23 Wards
¥6,000,000 - ¥7,000,000
Working with Professional in the market to develop your sklils
Rewarding and Challenging job will be provided
About Our Client
- Global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics
- Support for Quality problems of bio-process-related consumables (chromatography carriers / single-use products / cell culture media / process solutions, etc.) that are indispensable for manufacturing bio-pharmacy such as antibody drugs, vaccines, and cell drugs.
- Based on information from the head office about product defects, provide customers with prompt solutions and troubleshooting (status check, report to home country, suggestions to customers).
- Take care for quality improvement proposals to avoid problems.
- Respond to inquiries regarding matters related to quality and stable supply.
- Documentation management: Create, explain, and manage the GMP-related documents you need.
- Understand our quality management system, and prepare and explain documents necessary for written audits and on-site audits according to customer's request.
- Support for on-site audits of customers at overseas manufacturing bases.
- Compliant with necessary laws and regulations such as the Chemical Substances Control Law for selling products in compliance with domestic regulations.
The Successful Applicant
- Practical experience in complying with necessary laws and regulations such as the Chemical Substances Control Law for selling products in compliance with domestic regulations at domestic chemical manufacturers.
- Those who have knowledge of organic chemistry and inorganic chemistry.
- Bio-pharmacy manufacturing or process development, QA / QC work experience.
- Knowledge and experience to understand the technology used in pharmaceutical manufacturing and the quality requirements of customers, and to propose improvement measures.
- Concise and clear English writing skills, English Japanese summarizing skills, ability to build relationships with overseas staff.
What's on Offer