Pushpgandha Tiwari

Pushpgandha Tiwari Business Analyst Gurugram, Haryana - - LinkedIn SKILLS Business Analysis — BRD, FRD, SRS, Requirement Gathering, User Stories, Gap Analysis, MoSCoW Prioritization, Process Mapping, Wireframing Project Management — Agile, Scrum, JIRA/ Confluence, Project Planning, Risk Logs, Change Management, Sprint Tracking Healthcare & Pharma Expertise — Clinical Trials, Pilot Trials, Regulatory Frameworks (GxP, FDA, EMA), Life Sciences Compliance, Pharma Industry Processes, Validation & Audit Tools & Technical Skills — SQL (Basic), Tableau, Figma, Visio, Lucidchart, Advanced Excel, PowerPoint CERTIFICATES Certified SAFe Agilist- Scaled Agile Inc. Certified BA Professional -Simplilearn Jira/ Confluence PM -Great Learning PROFESSIONAL EXPERIENCE Business Analyst, Incedo Inc. Jul 2023 – present Pharma System Upgrade & Compliance- Led Server upgrade for a global pharma client; ensured full GxP compliance (FDA 21 CFR Part 11, GAMP 5). Agile Requirements & Collaboration- Defined 50+ user stories and acceptance criteria in JIRA; partnered with QA, Dev, Compliance, and SMEs. Risk & Regulatory Integration- Conducted impact assessments and integrated 25+ GxP and regulatory controls (FDA 21 CFR Part 11, GAMP 5) into validation testing and documentation. Centralized Validation & Specs- Authored BRD, FRD, SRS, RTM, Risk Logs, and IQ/OQ protocols using Confluence and Excel to centralize documentation. Diagrams for Docs & Decisions- Designed end-to-end workflows, process maps, and traceability diagrams in Lucidchart to support validation. UAT & Compliance Mapping- Co-developed 50+ UAT test cases and mapped results to compliance requirements. Agile Ceremonies & Delivery- Facilitated Agile ceremonies and tracked sprint progress, backlog refinement, and change control. SOPs, Training & Launch- Authored SOPs and led user training sessions, ensuring smooth go-live with minimal support required postdeployment. Key AchievmentsEnabled full GxP compliance for 3 different regulated projects with zero audit issues reported. Cut post-deployment queries by over 90% through documentation and training resources. Standardized validation docs through reusable templates and centralized Confluence-based documentation. • • • • • • • • • • • PROJECTS Legacy Application BRD Development Reverse-engineered 6 undocumented legacy systems by analyzing code, database structure, and functionality, and prepared BRDs and SRS to clarify system functions and support onboarding. • Conversational AI Chatbot for Protocol Automation Collaborated with cross-functional teams to develop a GenAI-powered chatbot automating protocol authoring for pharma trials. Defined and validated 70+ use cases for a pharma protocol chatbot across pilot modules. • • GxPilot Created an AI tool to auto-generate GxP-compliant test cases and RTMs using FRDs. Generated all requirement documents, workflows, and UI specifications and integrated compliance ready templates to reduce manual documentation. • • INTERNSHIPS Medical Writer, Casca Remedies Aug 2022 – Nov 2022 Created 80+ SEO-optimized blogs and marketing material, increased query requests by 30%, and authored several CSRs. • UX Researcher, Razorpod Developed design system (design tokens) and documentation for 3 client websites, improving UI consistency. Jan 2022 – Mar 2022 • Design & Marketing Intern, School Of Future Oct 2020 – May 2021 Designed and SEO-optimized websites on SquareSpace, driving a 35% organic traffic surge and enhanced Instagram engagement by 60-70% through strategic content and community management • EDUCATION Bachelor of Technology (B.Tech) in Biotechnology, Shoolini University Of Biotechnology & Management Sciences 2019 – 2023 | GPA: 8.92 EXTRACURRICULARS Marketing Director, TEDxShooliniUniversity — Led and managed marketing campaigns, driving engagement for 6 TEDx events. President, ChatterBox Club — Led the club, organized campus events, and mentored 70+ students in public speaking. Radio Jockey, Radio Shoolini Solan — Hosted and directed radio shows, and conducted interviews with notable local personalities.