Katalyst CRO
Overview
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. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Biotechnology Research and IT Services and IT Consulting
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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. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Biotechnology Research and IT Services and IT Consulting
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