IN-Senior Associate_CSV_ITRA_Advisory_Hyderabad
Core
Validating computer systems in regulated industries (GxP, FDA 21 CFR Part 11) to ensure compliance with quality and safety standards.
Role type
Senior Associate, Computer System Validation (CSV) Engineer
Builds
Validation deliverables (URS, FRS, IQ/OQ/PQ protocols, VSR) and compliant software systems for pharma/medical device clients
Domain
Life Sciences / Regulatory Compliance / Software Validation
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), GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+, Change Control, Deviation Management, CAPA, Periodic Review, Manual Testing (Positive/Negative, Regression, Smoke, Sanity), Defect Tracking, Validation Plan authoring, User Requirement Specifications, Functional Requirement Specifications, Functional Risk Assessment (FMEA), Design Specifications, IQ/OQ/PQ protocols, Validation Summary Report
Preferred skills
LIMS, QMS, Valgenesis
Technologies
Valgenesis, LIMS, QMS
Responsibilities
Authoring Computer System Validation deliverables including Validation Plans, URS, FRS, FRA, Design Specifications, and IQ/OQ/PQ protocols; Executing manual testing strategies (Positive/Negative, Regression, Smoke, Sanity) and managing defect tracking; Ensuring compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles; Managing Change Control, Deviation Management, CAPA, and Periodic Review processes; Applying SDLC methodologies (Waterfall, Agile, V-model) in regulated environments
Seniority
Senior, hands-on IC