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Updated 2024-03-08
Activated 2024-03-08

Site QA Specialist (Kanto) at Global Leading Biopharma

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  • Staff Level
This posting is managed by: 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
Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC
Medical/Pharmaceutical/Bio/Fabric/Food - Manufacturing Technology/Manufacturing Management
Medical/Pharmaceutical/Bio/Fabric/Food - Production R & D
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description Take lead in all support in the establishment of QMS as well as ensuring effective compliance at the company's site. Maintain all QA activities are aligned with GMP


Description

* Manage any local QC testing including packaging requirements to ensure specifications are correct
* Maintain products are aligned with effective compliance
* QA documents are following company SOPs with local standards
* Manage site change control activities and self inspection as well as supplier audits
* Execute investigation for quality issues such as complaints, deviations, and CAPA if necessary


Profile

* University degree in scientific or related environment
* Background in the pharmaceutical, chemical, physical, or related industry
* Experience in quality related work with GMP as well as GxPs
* Understanding of local regulations compliance as well as being able participate in PMDA inspections
* Pharmacist license preferred
* High fluency in English and Japanese (non-native level speakers will not be selected)


Job Offer

* Competitive salaries and benefits
* Great work life balance
* International working environment
* Work with industry leaders who are solving various unmet medical needs
* Amazing career progression in QA




Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info * One of the top global biopharma companies in the industry
* Rich development pipeline specializing in Oncology, Immunology, Immuno-Oncology, Fertility for unmet medical needs
* New product launch almost every other year
* Extensive communication with global HQ
* Hybrid working style
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Native Level
Salary JPY - Japanese Yen JPY 5000K - JPY 7500K   
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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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Site QA Specialist (Kanto) at Global Leading Biopharma

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