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Updated 2021-03-09
Activated 2021-03-05

QA specialist , Bio-Pharmaceuticals , Tokyo, 7M JPY

  • ★★ Staff Level
This posting is managed by:
Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name Company is not publicly visible
Job Type
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Manufacturing (Automobile/Plant Engineering/Precision Equipment) - Quality Control
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description * Understand company-wide goals and strategies to grow together with customers in the bio-pharmacy market, and carry out activities that contribute to the stable manufacturing and speedy launch of customers' drugs.
* Understand the characteristics of our products used in pharmaceutical manufacturing, responding to quality problems, and proposing quality improvements to their home countries.


Description

* 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.


Profile

* 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.


Job Offer

6M-7MJPY


To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Bon Siripairoj on +813 6832 8985.
Company Info * Global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics
Job
Requirements
*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.
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Business Level(JLPT Level 2 or N2)
Salary JPY - Japanese Yen JPY 6000K - JPY 7000K   
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Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社

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QA specialist , Bio-Pharmaceuticals , Tokyo, 7M JPY

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