CSV Team member

Location - Ahmedabad & Work hours - in office 5 days a week and two saturdays a month

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.

Required Skills

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.