24.09.2026 aktualisiert
40 % teilweise verfügbar
Senior CSV / GxP Validation Consultant
Israel
Nur Remote
B.Sc. Mathematics — University of MontrealÜber mich
I help pharma and biotech teams maintain compliant, inspection-ready computerized systems. With 8 years in GMP CSV, I provide remote support for validation planning, risk assessments, IQ/OQ/PQ, traceability, periodic reviews and audit-ready documentation. Fluent in English, French and Hebrew.
Skills
Computerized Systems Validation (CSV)
End-to-end CSV expertise covering the full validation lifecycle, including planning, requirements review, risk assessment, IQ/OQ/PQ, test execution, traceability, validation reporting, periodic reviews and maintenance of validated state in GMP-regulated pharmaceutical environments.
GxP / GMP Compliance & Regulatory Standards
Deep knowledge of GxP and GMP compliance frameworks, including 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, audit readiness and quality documentation to support regulatory inspections.
Risk Assessment & FMEA
Proficiency in conducting risk assessments and FMEA analyses for computerized systems, supporting change control, deviation investigations, CAPA activities and lifecycle documentation for GxP systems.
Validation Strategy & Lifecycle Management
Development and execution of validation strategies, protocols, plans and reports across enterprise applications, ERP systems, manufacturing systems, laboratory systems and IT infrastructure.
SAP & ERP System Validation
Hands-on experience supporting SAP validation and qualification activities for Priority ERP, Infor M3 (Movex ERP), GE CIMPLICITY, Sensitech, CombiStats, GlobalProtect and other computerized systems.
Cross-functional Collaboration
Extensive collaboration with QA, IT, Engineering, Manufacturing, Automation, vendors and business stakeholders to deliver inspection-ready validation documentation and evidence.
Systems & Technologies
Practical experience with SAP, JIRA, Priority ERP, Infor M3 (Movex ERP), GE CIMPLICITY, Sensitech, CombiStats, GlobalProtect, Pharmaceutical Network Qualification, Pro Aerosol Particle Counter, Manufacturing Systems and Laboratory Systems.
Pharmaceutical Network Qualification
Support for pharmaceutical network qualification activities and computerized system compliance, including data integrity activities across regulated environments.
CAPA & Change Control
Support of change control processes, deviation investigations and CAPA activities to maintain the validated state of computerized systems in GMP environments.
End-to-end CSV expertise covering the full validation lifecycle, including planning, requirements review, risk assessment, IQ/OQ/PQ, test execution, traceability, validation reporting, periodic reviews and maintenance of validated state in GMP-regulated pharmaceutical environments.
GxP / GMP Compliance & Regulatory Standards
Deep knowledge of GxP and GMP compliance frameworks, including 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, audit readiness and quality documentation to support regulatory inspections.
Risk Assessment & FMEA
Proficiency in conducting risk assessments and FMEA analyses for computerized systems, supporting change control, deviation investigations, CAPA activities and lifecycle documentation for GxP systems.
Validation Strategy & Lifecycle Management
Development and execution of validation strategies, protocols, plans and reports across enterprise applications, ERP systems, manufacturing systems, laboratory systems and IT infrastructure.
SAP & ERP System Validation
Hands-on experience supporting SAP validation and qualification activities for Priority ERP, Infor M3 (Movex ERP), GE CIMPLICITY, Sensitech, CombiStats, GlobalProtect and other computerized systems.
Cross-functional Collaboration
Extensive collaboration with QA, IT, Engineering, Manufacturing, Automation, vendors and business stakeholders to deliver inspection-ready validation documentation and evidence.
Systems & Technologies
Practical experience with SAP, JIRA, Priority ERP, Infor M3 (Movex ERP), GE CIMPLICITY, Sensitech, CombiStats, GlobalProtect, Pharmaceutical Network Qualification, Pro Aerosol Particle Counter, Manufacturing Systems and Laboratory Systems.
Pharmaceutical Network Qualification
Support for pharmaceutical network qualification activities and computerized system compliance, including data integrity activities across regulated environments.
CAPA & Change Control
Support of change control processes, deviation investigations and CAPA activities to maintain the validated state of computerized systems in GMP environments.
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2025
Sprachen
EnglishMutterspracheFrenchMutterspracheHebrewverhandlungssicher
Projekthistorie
Lead end-to-end Computerized Systems Validation activities for GMP-regulated pharmaceutical environments. Develop and execute validation plans, protocols, IQ/OQ/PQ, traceability matrices, test documentation and validation reports. Perform requirements review, risk assessments, periodic reviews and lifecycle documentation for GxP computerized systems. Validate enterprise applications, ERP, manufacturing systems, laboratory systems and IT infrastructure. Support SAP validation and qualification activities for Priority ERP, Infor M3 (Movex ERP), GE CIMPLICITY, Sensitech, CombiStats, GlobalProtect and other computerized systems. Support change control, deviation investigations, CAPA activities and maintenance of validated state. Perform pharmaceutical network qualification and support computerized system compliance and data integrity activities. Collaborate with QA, IT, Engineering, Manufacturing, Automation, vendors and business stakeholders. Support internal and external audit readiness through inspection-ready validation documentation and evidence.
Managed validation projects from planning through final approval. Prepared validation strategies, protocols, reports and FMEA documentation. Coordinated validation deliverables across QA, Engineering, IT and project stakeholders.