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CSV Analyst

CSV Analyst

Mantell AssociatesBraine-l’Alleud, Walloon Region, Belgium
Il y a 16 jours
Description de poste

Mantell Associates is looking for a CSV Analyst to join a high-impact SAP S / 4 HANA transformation project in a compliance-driven role.

In this role, you’ll play a key part in ensuring that validation and compliance requirements are met throughout the project, aligning all systems and processes with internal quality standards and global regulatory guidelines.

CSV Analyst - Responsibilities :

  • Ensure all validation activities within the SAP S / 4 HANA program comply with regulatory and internal CSV standards
  • Coordinate validation tasks and timelines in close collaboration with internal teams and third-party vendors
  • Translate business and compliance needs into concrete validation deliverables
  • Prepare and review validation documentation, including URS, FS, RTM, test strategies, test scripts, and summary reports
  • Support internal and external audits by delivering complete, audit-ready validation records
  • Provide regular updates on validation progress in project meetings and proactively raise potential risks or issues
  • Contribute to the investigation and resolution of validation-related deviations, including root cause analysis and CAPA
  • Promote a collaborative, quality-focused project culture through cross-functional engagement

CSV Analyst - Requirements :

  • Minimum of 3 years' experience in SAP validation within regulated (GxP) environments
  • Strong understanding of CSV frameworks and regulatory requirements (GxP, FDA, EMA, GAMP 5)
  • Familiarity with pharmaceutical manufacturing processes and SAP QM (Quality Management) modules
  • Demonstrated expertise in authoring and managing validation documentation across the system lifecycle
  • Experience working in complex stakeholder environments, especially within matrix organizations
  • Hands-on experience with SAP ECC and / or S / 4 HANA, particularly in compliance contexts
  • Ability to manage multiple tasks and priorities independently with strong organizational skills
  • Fluent in English (written and spoken), with excellent communication and documentation skills
  • Working knowledge of French and / or Dutch is a plus

    • Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

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