8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.

Benefits

Contract

Period: 6-12 months

Location: Work from Office Ahmedabad

Compétences requises

Computer System Validation (CSV)GxP regulations knowledgeFDA regulatory requirementsValidation Plan developmentRisk Assessment for validated systemsUser Requirements Specification (URS) and Functional Specification (FS) authoringTraceability Matrix creation and maintenanceTest script authoring and execution (SIT/UAT)IQ/OQ/PQ protocol development and executionValidation Summary Report preparation and reviewData integrity assurance in regulated environmentsAudit readiness and regulatory compliance reviewsDefect management and remediation coordinationSAP implementation validation and hypercare supportGo‑live readiness, document signoffs and change control

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