IN_Senior Associate_CSV_ITRA_Advisory_Mumbai
Core
Senior Associate in Computer System Validation (CSV) and IT Compliance, ensuring software systems in regulated industries meet regulatory standards and quality requirements.
Role type
Senior IC CSV & IT Compliance Specialist
Builds
Validated computer systems, validation documentation, and compliance assessments for regulated industries
Domain
Life Sciences / Healthcare / Regulated Industries (GxP, FDA, EU)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Software Testing (Manual, Regression, Smoke, Sanity), SDLC/STLC methodologies (Waterfall, Agile, V-model), GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, Change Control, Deviation Management, CAPA, Periodic Review, Validation Plan (VP), URS, FRS, FRA (FMEA), Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)
Preferred skills
LIMS, QMS, Valgenesis
Technologies
Valgenesis, LIMS, QMS
Responsibilities
Author validation deliverables including URS, FRS, FRA, DS, IQ/OQ/PQ protocols, and VSR; execute manual testing (positive, negative, regression, smoke, sanity); manage change control, deviations, CAPA, and periodic reviews; assess compliance with GxP, FDA 21 CFR Part 11, and EU Annex 11; support SDLC and STLC processes.
Seniority
Senior, hands-on IC