Csv Consultant - SAP HANA & GxP Systems

Role & responsibilities

Strategic Responsibilities:

• Define and govern the

  corporate CSV strategy

  across all units/sites for GxP systems, including SAP HANA.
• Lead

  enterprise-wide validation projects

  ensuring alignment with

  GAMP 5

  ,

  21 CFR Part 11

  ,

  EU Annex 11

  , and global data integrity expectations.
• Establish and monitor corporate SOPs, templates, and risk-based approaches for computer system validation.

SAP HANA Specific Responsibilities:

• Lead validation of

  SAP S/4HANA (MM, QM, PP, and Z-reports, workflows, GRN process)

  across GxP operations.
• Prepare and maintain validation documentation including

  URS, Functional Specs, Test Scripts (IQ/OQ/PQ), RTM, and final reports

  for SAP HANA modules.
• Coordinate with IT, SAP consultants, and business users to ensure change management, role-based access control(RBAC), audit trail configuration, and secure workflows.
• Evaluate SAP-integrated systems (e.g.,LIMS, QMS, DMS) and their GxP compliance status.

Cross-System & Governance Responsibilities:

• Ensure

  centralized control and compliance

  of all validated GxP systems across manufacturing, QC, QA, warehouse, and R&D operations.
• Conduct

  CSV risk assessments, gap analyses

  , and ensure mitigation plans are implemented across systems.
• Support system onboarding, upgrades, and infrastructure changes from a validation standpoint.
• Lead or support

  regulatory inspections and customer audits

  as CSV SME.
• Develop and lead

  training programs

  on computer system validation, data integrity, and regulatory compliance.
• Manage a team or act as a corporate mentor for site-level CSV resources.

Preferred candidate profile:

Technical Competencies:

• Strong knowledge of:

• SAP HANA MM, QM, PP, GRN workflows, custom Z-reports

• GAMP 5 / V-model SDLC / Agile methodologies

• 21 CFR Part 11 / EU Annex 11 / WHO / PIC/S data integrity guidance

Soft Skills & Corporate Traits:

• Strong

  leadership and coordination

  skills for multi-site operations
• Excellent

  documentation, audit readiness, and training

  capabilities
• Capability to represent the organization in

  global audits and customer discussions

• Strong

  cross-functional communication

  with IT, QA, QC, Regulatory, and external vendors