GxP Compliance & Validation Planning Consultant

Added
1 hour ago
Type
Full time
Salary
Salary not provided

Related skills

data integrity gxp sap s/4hana eu annex 11 fda 21 cfr part 11

📋 Description

  • Support the GxP and validation strategy for the SAP S/4HANA program
  • Coordinate validation planning across workstreams, releases, and deployment phases
  • Align with GxP regs, internal standards, CSV/CSA, and data integrity
  • Advise leadership on compliance impacts in system implementations
  • Define validation deliverables, governance, and documentation
  • Review validation plans and guidance produced by implementation teams

🎯 Requirements

  • 7+ years in GxP-regulated environments
  • Experience supporting validation and compliance for large enterprise systems
  • Experience with SAP ERP or SAP S/4HANA transformation programs
  • GAMP 5, CSV/CSA, FDA 21 CFR Part 11, EU Annex 11, data integrity
  • Experience coordinating cross-functional stakeholders in complex programs
  • Familiarity with validation lifecycle documentation and governance processes

🎁 Benefits

  • Open and inclusive team culture
  • Transparent team spirit and collaboration
  • Challenging projects with new ideas
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