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SAP Validation Lead

SAP Validation Lead

Katalyst Healthcares and Life SciencesFoster City, CA, United States
2 days ago
Job type
  • Full-time
Job description

Job Description :

  • We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards.
  • This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes. You will collaborate closely with Business, IT, QA, and Regulatory stakeholders to ensure compliance, system integrity, and data reliability.

Responsibilities :

  • SAP System Validation & Compliance.
  • Lead end-to-end validation of SAP systems in line with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
  • Develop and execute validation strategies, IQ, OQ, PQ protocols, and test scripts.
  • Ensure documentation aligns with GAMP 5, FDA, and industry standards.
  • Validation Documentation & Risk Assessment.
  • uthor, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
  • Conduct impact assessments, risk evaluations, and periodic system reviews.
  • Change Control & Incident Management.
  • Lead Change Control assessments for SAP updates, patches, and customizations.
  • Ensure incident management, deviations tracking, and CAPA resolution.
  • Collaboration & Stakeholder Management.
  • Partner with Business, IT, and QA teams to align validation with business needs.
  • ct as the SAP Validation SME during internal and external audits.
  • System Decommissioning & Lifecycle Management.
  • Oversee system decommissioning with full compliance and documentation.
  • Drive continuous improvement for validation processes.

    • Requirements :

  • 8+ years in SAP validation, compliance, and CSV within Pharma, Life Sciences, or Medical Devices.
  • Strong knowledge of SAP ECC, S / 4HANA, SAP GxP, SAP QM, SAP MM, SAP WM.
  • Expertise in validation deliverables (URS, FRS, IQ, OQ, PQ, Validation Reports).
  • Experience with GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+ compliance.
  • Hands-on with change management, incident tracking, and system reviews.
  • Strong understanding of data integrity, security controls, and electronic record-keeping.
  • Excellent documentation skills with Good Documentation Practices (GDP).
  • Strong problem-solving, communication, and stakeholder engagement abilities.
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    Validation Lead • Foster City, CA, United States

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