Sristi Sengupta
Computer System Validation | Quality Control Compliance | Analyst | Project Coordinator | Medical Device | Pharmaceutical
- Role
- Digital Quality Compliance Analyst (Global Pharma Major) at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sristi Sengupta
Impact-driven CSV, Compliance, and Validation Analyst with 9+ years of overall experience,including Life Sciences, Medical Devices, and Pharma domains. Expertise in ComputerSystem Validation (CSV), GxP Compliance, Validation & Verification, Gap Assessment & Remediation, and Digital Quality Systems. Strong understanding of FDA, 21 CFR Part 11, ISO13485, and GAMP 5 regulations.
Experience
Digital Quality Compliance Analyst (Global Pharma Major)
Feb 2023 — Present · Bangalore, IN
Provided regulatory and compliance support for SaaS and QMS applications.• Executed CSV deliverables including Plan, URS, FS, IQ, OQ, PQ, RTM, and SummaryReports.• Conducted Gap Assessment and Remediation activities.• Supported audits and CAPA activities.• Ensured compliance with FDA, 21 CFR Part 11, and GAMP 5.• Migration of SDLC Documents as per business acquirement and template changes,maintaining Good documentation practice.• Knowledge of Medical device, capital equipment, such as ophthalmic surgical devices,minimally invasive devices.• Collaborated with SMEs, Business, and technical teams.
Education
SASTRA University
Master of Computer Applications - MCA
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