IN_Associate_CSV_ITRA_Advisory_Bangalore
Core
Ensuring compliance of computerized systems in regulated industries through validation, testing, and adherence to GxP/FDA guidelines.
Role type
Associate Computer System Validation (CSV) Engineer
Builds
Validated computer systems, validation protocols, and compliance documentation for regulated environments.
Domain
Life Sciences / Healthcare / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Software Testing Life Cycle (STLC), SDLC methodologies (Waterfall, Agile, V-model), Manual testing (Positive/Negative, Regression, Smoke, Sanity), GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, Change Control, Deviation Management, CAPA, Periodic Review, Validation Plan (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Functional Risk Assessment (FRA), IQ/OQ/PQ protocols, Validation Summary Report (VSR)
Preferred skills
Valgenesis, LIMS, QMS
Technologies
Valgenesis, LIMS, QMS
Responsibilities
Execute manual testing (Positive/Negative, Regression, Smoke, Sanity) and defect tracking; Author validation deliverables including URS, FRS, FRA, IQ/OQ/PQ protocols, and VSR; Ensure compliance with GAMP5, GxP, FDA 21 CFR Part 11, and EU Annex 11; Manage change control, deviation management, and CAPA processes.
Seniority
Associate, 4-8 years experience
