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CSV Project Manager


勤務地: 日本
給与: Negotiable
職種: 正社員
専門: IT, 製薬・メディカルディバイス, SE・ソフトウェアエンジニア
参照: BBBH43470_1678173486
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We are looking for a bilingual, Japanese-speaking Computer System Validation (CSV) Project Manager for an exciting healthcare company.

Snapshot of the role's responsibilities:

  • Resolution of fundamental CSV compliance issues
  • Align with e‐Compliance on project management and life-cycle documentation for GxP projects
  • Managing risks and validating deliverables for GxP and tested for non‐GxP in line with SOPs and CSV requirements
  • Deviation reporting; collecting and managing the user requirements from various departments into specifications and details, including support to establish user requirements, IQ/OQ/PQ documentation
  • Implementing document traceability, retaining document repository (Document Navigator) and approved in accordance to the prescribed SOPs
  • Remote work available.


  • Technical university degree (Engineering, Chemistry, Informatics,..)
  • Strong experience in pharmaceutical companies doing, eg, equipment validation, computerised systems validation, quality control
  • Knowledge of GMPs requirements
  • Knowledge of ALCOA and GAMP practices
  • Bilingual: Japanese (N1 to native); and English (at least TOEIC 750/CEFR B2)
  • Availability to Travel up to 20% of working week.

About the company:

  • Started in 1998 with global operations; since 2017 in Japan and growing with strength and steadiness
  • Strong diversity-and-inclusion: women-owned
  • Complete quality solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry
  • Supporting clients in maintaining compliance with the latest regulations.

Expired Job

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