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.
• Author, 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.
• Act 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.

• 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.
• Author, 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.
• Act 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