IN-Specialist_CSV_ITRA_Advisory_Bangalore
Core
Specialist in Computer System Validation (CSV), Software Testing, and IT Compliance supporting audit and assurance services.
Role type
Specialist IC in IT Compliance and CSV
Builds
Validation deliverables (URS, FRS, IQ/OQ/PQ protocols, VSR) and audit assessments for regulated industries
Domain
Life Sciences / Healthcare / Regulated Industries
Required skills
Computer System Validation (CSV), Software Testing, SDLC/STLC, GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11, ALCOA+, Change Control, Deviation Management, CAPA, Periodic Review, Manual Testing, Defect Tracking
Preferred skills
Valgenesis, LIMS, QMS
Technologies
Valgenesis, LIMS, QMS
Responsibilities
Author Validation Plans, User Requirement Specifications, Functional Requirement Specifications, Functional Risk Assessments, Design Specifications, IQ/OQ/PQ protocols, and Validation Summary Reports; Execute manual testing (Positive/Negative, Regression, Smoke, Sanity); Manage Change Control, Deviations, and CAPA processes; Assess compliance with GxP and regulatory standards.
Seniority
Specialist, 4-8 years experience