Nikhil Bharti
CSV- Domain Consultant- Life Science | Gen AI |Technical Writing | GxP, SoX compliance | End-to-End SDLC Agile & Hybrid Exposure | Driving Process Excellence | MBA Finance – BHU
- Role
- Senior Associate Consultant at Infosys
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Nikhil Bharti
Detail-driven Technical Writer at Infosys with 3+ years of experience supporting global pharmaceutical clients in highly regulated environments. My work spans Computer System Validation (CSV), GxP compliance, SOX compliance, SDLC documentation, and cross-functional stakeholder communication.Backed by an MBA in Finance from BHU, Varanasi, I bring both business acumen and process insight, bridging gaps between technical teams, compliance stakeholders, and product objectives.
Experience
Senior Associate Consultant
Jun 2022 — Present · Pune, IN
Experienced Computer System Validation (CSV) Associate with expertise in drafting SOPs, validation protocols, and compliance documentation for pharmaceutical and GxP-regulated environments. Well-versed in applying 21 CFR guidelines and GAMP 5 principles to ensure robust system validation, compliance, and data integrity. Skilled in collaborating across quality, IT, and regulatory functions to streamline validation, support change control, and maintain audit-ready documentation. Proven track record of leveraging risk-based, lifecycle approaches and industry best practices to deliver reliable, compliant outcomes for critical systems.
Education
Indira Gandhi Krishi Vishwavidyalaya, Raipur
Bachelor of Technology
2014 — 2018
Institute of Management Studies, Banaras Hindu University
Master of Business Administration - MBA
2020 — 2022
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