From: Ukraine
Location: Kharkiv, UA
On Useme since 7 March 2025
About me
🔬 GxP/CSV Validation & Quality Systems: CSV documentation aligned with GAMP 5, GxP, FDA 21 CFR Part 11 and EU Annex 11. Deliverables: URS/FRS, validation plans, FMEA, DQ/IQ/OQ/PQ protocols, RTM and Validation Summary Reports. Data integrity, audit trails, electronic records/signatures, change control, deviations and traceable evidence.
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⚙️ Software Consulting & Systems Analysis: Functional analysis of SaaS, LIMS/ELN, QMS and enterprise systems: workflows, rules, permissions, integrations, dependencies, gaps, edge cases and change impacts. Requirements clarification for product, engineering and QA teams.
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📝 Technical Writing & Business Analysis: SRS, BRD, URS, functional specifications, SOPs, work instructions, user guides, process documentation, acceptance criteria, requirements traceability and process models. Focus on clear scope, testable requirements and usable documentation.
Categories
CV / Résumé
Mar 2024 - Now
Systems Analyst & Validation
Confidential
Business and systems analysis, technical documentation, and risk-based computerized systems validation (CSV) for a multimodule enterprise SaaS platform supporting laboratory R&D operations and regulated workflows.
Jan 2024 - Now
Software Consultant, Technical Writer
Confidential
Business and systems analysis, software requirements engineering, technical documentation, and consulting for enterprise SaaS, regulated software, and data-intensive applications.
Jan 2019 - Jan 2025
Software Consultant
Confidential
Business and systems analysis, software requirements engineering, technical documentation, and consulting for enterprise SaaS, regulated software, and data-intensive applications. Development of BRD, SRS, FRS, URS, PRD for SaaS enterprise platforms.