Bhagyashri Patil on Tal
Headline
CSV/ITQA Specialist|Quality Compliance| GXP | 21 CFR Part 11 | EU GMP Annexure 11 Requirements | Data Integrity | GAMP | V Model | Ensuring Regulatory Compliance & Risk Mitigation.
About
Validated 20+ computerized systems including global software platforms, PLC/SCADA, laboratory instruments, and client-server applications in a regulated pharmaceutical manufacturing environment. I work in Computerized System Validation (CSV) and IT Quality Assurance (ITQA), managing the full validation lifecycle aligned with GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. My expertise includes System Impact Assessment (SIA), risk-based validation, URS/FRS development, IQ/OQ/PQ execution, RTM, VSR preparation, and audit-ready documentation. I have hands-on experience validating LabSolutions (Shimadzu), Chromeleon CDS, PLC/SCADA/HMI systems, analytical instruments (UV, FTIR, TOC, Viscometer), and client-server/web-based platforms. My work ensures data integrity (ALCOA+), audit trail review, role-based access control (RBAC), electronic records compliance, and infrastructure qualification. Beyond execution, I contribute to handling Discrepancies,vendor assessment, periodic review, and inspection readiness — supporting strong GxP and cGMP compliance frameworks. I am particularly interested in UK/EU regulatory-focused CSV/ITQA roles where I can strengthen compliance systems and support global regulatory standards. Open to opportunities in Computerized System Validation and IT Quality Assurance.
Work experience
CSV/ITQA Specialist at Emcure Pharmaceuticals Limited, May 2025 - Present · 1 yr 1 mo, Gujrat,india
Computerized System Validation (CSV) Engineer at KVS Technologies and Infra Control Systems, Sep 2024 - May 2025 · 9 mos, Computer system validation - GAMP, V Model, 21 CFR Part 11, EU Annexure 11 Validation - PLC, SCADA, HMI Base system Analytical Instruments - HPLC, GC, UV,IR, Polorimtere, FTIR Project - Standalone System, Server client system. Regulatory Compliance and Risk Mitigation USFDA, MHRA, ANVISA EU
Education
Bachelor of Pharmacy - BPharm, Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration, Shriman suresh Dada Jain college of pharmacy chandwad
