Csv Consultant - SAP HANA & GxP Systems

8 - 13 years

12 - 16 Lacs

Posted:2 weeks ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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

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