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Tier-1 employer increases applicant interest but niche CSV/GxP expertise limits candidate pool.
Requires specialized regulated-industry CSV and GxP expertise, limiting cross-industry transferability.
Multiple mandatory GxP, 21 CFR Part 11, GAMP5 and validation project requirements increase filtering stringency.
Own end-to-end Computerized System Validation (CSV) projects ensuring compliance with client SDLC and regulatory frameworks.
Manage assessments and validations related to GxP, 21 CFR Part 11, EU Annex 11, and ensure regulatory compliance.
Act as subject matter expert for CSV and Quality Risk Management, coordinating incident management and change control processes.
Experience in computer system validation involving FDA regulated environments and cGxP compliance.
Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 guidelines, and relevant quality regulations.
Educational qualification: Graduate in BE/B.Tech (CS/IT/EC/E) or MCA from recognized university.
Work Experience Required: Not explicitly mentioned in the JD.
Demonstrated ability to manage and deliver multiple end-to-end CSV projects in regulated environments.
Proficient in quality systems such as CMMi or ISO with deep understanding of validation and qualification processes.
Skilled in coordinating cross-functional compliance activities and acting as CSV technical SME in Cyber Strategy contexts.