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Updated 2025-04-26
Activated 2025-04-26

QA Sr. Specialist GQP at Top Global Pharma

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
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description Be part of one of the top global pharmaceutical companies in the industry. Take lead in GQP QA activities to ensure effective compliance.


Description

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Ensure GQP Compliance: Oversee GQP Quality Assurance activities, ensuring alignment with policies, regulations, and global requirements.
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Manage Quality Systems: Collaborate with manufacturing sites to implement and maintain effective quality systems and manage deviations, investigations, and change controls.
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Support Regulatory Filings & Audits: Assist with regulatory filing updates, new product launches, and conduct routine GMP audits, addressing any gaps.
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Conduct Due Diligence & Compliance: Perform quality assessments for new partners and ensure compliance with regulatory requirements, including pharmacopeia updates and new regulations.
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Cross-Functional Collaboration: Work closely with various departments and external partners to support business development, regulatory inspections, and ensure stable product supply.


Profile

* University degree in scientific or related environnment
* High fluency in English and Japanese
* QA experience in the pharmaceutical industry
* Strong understanding of GMP and GQP within GxPs


Job Offer

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




Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info * One of the top global companies in the industry
* Rich development pipeline for unmet medical needs
* Specializing in oncology, vaccines, infectious diseases, neuroscience, immunology etc.
* Several blockbuster products
* International working environment
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Native Level
Salary JPY - Japanese Yen JPY 8000K - JPY 10000K   
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