Validation Analyst
Axtria · Noida · onsite · Posted 35d ago
Undisclosed0–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Position Summary
To be a driven business analyst who can work on complex Analytical problems and help the customer in better business decision making especially in Pharma (domain).
Job Responsibilities - Develop validation plans aligned with GAMP 5, leveraging Veeva's platform validation evidence where applicable
- Author validation deliverables: Validation Plan, URS, FRS, Risk Assessment, IQ/OQ/PQ protocols, Traceability Matrix, Validation Summary Report
- Execute OQ/PQ scripts on client-specific configuration and customizations; document evidence and manage deviations
- Assess impact of Vault's periodic releases and author release-qualification evidence
- Coordinate with business SMEs, QA, and client compliance teams on reviews and approvals
- Ensure Part 11 controls: electronic signatures, audit trail, access control are correctly configured in Vault
- Support audit readiness and respond to internal/external audit queries
- Maintain validation documentation in an eQMS (Veeva QualityDocs, MasterControl, TrackWise, etc.)
- Bachelor of Engineering
- Master of Computer Application in Information Technology or Computer
- 0-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company Business Operation Technology
- Teamwork Leadership
- Motivation to Learn and Grow
- Ownership
- Cultural Fit
- Problem Solving
- Lifescience Knowledge
- Communication
- Capability Building / Thought Leadership
Sourced from naukri
Skills
QAExternal AuditHashiCorp VaultGamptrackwiseBusiness AnalystCapability BuildingRisk AssessmentIT ServicesInformation TechnologycompliancePharma
About Axtria
Axtria
Software Product
2.8k+
employees
2010
16 years old
Gurgaon/Gurugram, Haryana
India
About
Axtria provides cloud software and data analytics solutions to the life sciences sector, enhancing product commercialization and improving healthcare outcomes.
Industries
Software ProductInternetIT Services & Consulting
Employee ratings
783 reviews
2.8/ 5
Culture
2.6
Career growth
2.7
Work-life
2.6
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