IN_Associate_CSV_ITRA_Advisory_Mumbai
Core
Associate role in Computer System Validation (CSV) and IT Compliance, ensuring software systems in regulated industries meet regulatory standards and quality requirements.
Role type
Associate, hands-on IC in IT Compliance and CSV
Builds
Validated computer systems and software for regulated industries (pharma, medical devices)
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, IT Compliance, SDLC/STLC methodologies, Manual Testing, GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11, ALCOA+, Change Control, Deviation Management, CAPA, Validation Documentation (VP, URS, FRS, FRA, IQ/OQ/PQ, VSR)
Preferred skills
LIMS, QMS, Valgenesis
Technologies
Valgenesis
Responsibilities
Execute manual testing (positive, negative, regression, smoke, sanity), author validation deliverables (plans, specs, protocols, reports), assess compliance with GxP and regulatory guidelines, manage change control and deviations.
Seniority
Associate, 4-8 years experience