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Job Description
Role Description
- 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.
Skills
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About Company
We deliver digital transformation of businesses through IP-led products and cognitive solutions, growth accelerators and innovative outcome-based business models. Our solutions span across Digital Journey Management, Predictive Analytics, Digital Customer Experience, Payments & Citizen services and Education. Incepted in 1999, we have worked with Fortune 500 companies 1000+ Enterprise Customers, 3500+ SME Customers and 475+ Universities across twenty countries in North America, Middle East, India, Far East, and Africa. With innovation and thought leadership as our core values, we have delivered sustainable transformation to customers, adapting advancements in technology specific to each business domain allowing them to function with agility and create new business models besides being ready for the changes and challenges of the future.
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