- Validation and compliance
- Computer System Validation (CSV), IQ/OQ/PQ, Process Validation, Equipment Qualification, Validation Plans and Summary Reports, Requirements Traceability, Risk Assessment, Change Control, CAPA and Deviation Management, Audit Readiness
- Regulatory frameworks
- FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971, GAMP 5, GxP, SaMD
- Testing
- Manual, Functional, Regression, Integration, UAT, Exploratory, Smoke and Sanity, Accessibility, Defect Triage and Lifecycle Management, Test Automation (Selenium, Playwright, Cypress), API Testing (Postman)
- Data and analysis
- Python, SQL, Power BI, Data Integrity Validation, Data Profiling, Root Cause Analysis
- Building
- React, Next.js, JavaScript, Supabase, Stripe Connect, Git and GitHub, UI/UX Design, Product Specification and User Stories
- Platforms and tools
- JIRA, Confluence, Power Apps, Power Automate, Dataverse, SharePoint, Microsoft 365, Azure AD, Jenkins
- AI-assisted workflows
- Claude, ChatGPT, Microsoft Copilot, AI-assisted test scoping and generation