CSV Consultant

CSV Consultant

Posted Today by Next Ventures

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Negotiable
Undetermined
Hybrid
Tokyo, Japan
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Computer Systems Computer System Validation External Auditing Management SAP Applications Stakeholder Management Traceability Matrix Verification And Validation

Summary: The role of a Japanese Speaking SAP CSV Consultant involves leading and supporting Computer System Validation (CSV) activities within a global SAP S/4HANA implementation for a major transformation programme in Japan. The consultant will develop validation documentation, ensure compliance with regulatory requirements, and collaborate with various stakeholders. This position offers an opportunity to work on a complex global project while utilizing Japanese language skills. The role is contract-based with potential for extension.

Key Responsibilities:

  • Lead and support Computer System Validation (CSV) activities within a global SAP S/4HANA implementation.
  • Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices and Validation Reports.
  • Ensure compliance with GxP, regulatory and quality requirements throughout the project lifecycle.
  • Collaborate with business stakeholders, quality teams, system integrators and technical teams to define validation requirements.
  • Support testing activities and review test evidence to ensure compliance with validation standards.
  • Participate in audit readiness activities and support internal and external audits where required.
  • Work closely with global programme teams to align validation processes across regions and workstreams.
  • Provide guidance on validation best practices within SAP S/4HANA environments.

Key Skills:

  • Proven experience as a CSV Consultant within regulated environments.
  • Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11 and related compliance frameworks.
  • Experience supporting large-scale SAP programmes, ideally SAP S/4HANA implementations.
  • Hands-on experience creating and managing validation deliverables and documentation.
  • Strong stakeholder management and communication skills.
  • Ability to work effectively within large, complex global transformation programmes.
  • Fluent Japanese language skills (spoken and written).
  • Business-level English communication skills.

Salary (Rate): undetermined

City: Tokyo

Country: Japan

Working Arrangements: hybrid

IR35 Status: undetermined

Seniority Level: undetermined

Industry: IT

Detailed Description From Employer:
Ref: #73807

CSV Consultant

  • Practice SAP

  • Technologies SAP Technology Jobs

  • Location Tokyo, Japan

  • Type Contract

Japanese Speaking SAP CSV Consultant – S/4HANA Global Transformation Programme

We are currently seeking an experienced Japanese Speaking SAP CSV Consultant to join a major global SAP S/4HANA transformation programme being delivered by a leading consulting organisation for one of its strategic enterprise customers in Japan.

This is an opportunity to work on a very large and complex global S/4HANA programme, supporting the validation and compliance workstream across multiple business and technology functions.

Key Responsibilities

  • Lead and support Computer System Validation (CSV) activities within a global SAP S/4HANA implementation.

  • Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices and Validation Reports.

  • Ensure compliance with GxP, regulatory and quality requirements throughout the project lifecycle.

  • Collaborate with business stakeholders, quality teams, system integrators and technical teams to define validation requirements.

  • Support testing activities and review test evidence to ensure compliance with validation standards.

  • Participate in audit readiness activities and support internal and external audits where required.

  • Work closely with global programme teams to align validation processes across regions and workstreams.

  • Provide guidance on validation best practices within SAP S/4HANA environments.

Required Skills & Experience

  • Proven experience as a CSV Consultant within regulated environments.

  • Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11 and related compliance frameworks.

  • Experience supporting large-scale SAP programmes, ideally SAP S/4HANA implementations.

  • Hands-on experience creating and managing validation deliverables and documentation.

  • Strong stakeholder management and communication skills.

  • Ability to work effectively within large, complex global transformation programmes.

  • Fluent Japanese language skills (spoken and written).

  • Business-level English communication skills.

Desirable Experience

  • Experience within Life Sciences, Pharmaceuticals, Medical Devices or other highly regulated industries.

  • Previous experience working with global system integrators or consulting organisations.

  • Knowledge of SAP Quality Management (QM), SAP Manufacturing or Supply Chain processes.

  • Experience working in international project environments with distributed teams.

What's on Offer

  • Opportunity to work on a flagship global SAP S/4HANA transformation programme.

  • Long-term contract engagement with strong extension potential.

  • Exposure to senior stakeholders across a complex multinational environment.

  • Collaborative international project team with significant programme visibility.

If you are a Japanese-speaking CSV professional with SAP programme experience and are looking to join a high-profile global transformation initiative, we would be delighted to hear from you.

Location: Japan (Hybrid/Remote with occasional client site travel)
Duration: Initial 12-month contract (extension likely)
Language Requirements: Fluent Japanese and Business English
Start Date: ASAP
Team Contact: shakeel.safdar@next-ventures.com

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