Nitish Saxena
Senior Solution Consultant |QMS|TrackWise|Veeva Vault|CQ|TrackWise Digital Certified
- Role
- Senior Consultant at Deloitte
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Nitish Saxena
With over a decade of experience in the IT industry, I specialize in providing solutions within the Life Sciences domain, focusing on Quality Management Systems (QMS) and Regulatory Compliance. Currently serving as a Veeva/TrackWise Senior Consultant at Deloitte, I bring expertise in implementing and managing TrackWise Digital, Veeva CRM, and Veeva RIM solutions, ensuring adherence to FDA regulations and 21 CFR Part 11. My work emphasizes designing workflows, configuring systems, and supporting TrackWise Digital to streamline processes such as audits, CAPA, and adverse event reporting. Collaborating with pharmaceutical organizations, I contribute to improving compliance and operational efficiency using advanced QMS tools.
Experience
Senior Consultant
Jul 2025 — Present · Hyderabad, IN
I joined Deloitte and have 13 years of hands-on experience in eQMS, including solution architecture, configuration, validation, and enhancements across TrackWise - On Prem and Digital, Veeva Vault platforms, ComplianceQuest
Education
SRM IST Chennai
Bachelor of Technology (B.Tech.), electronics and communication
2008 — 2012
Spring Dale College
High School
2005 — 2006
Skills
- Trackwise
- Capa
- Management
- Sql
- Linux
- Pl/Sql
- Core Java
- Change Control
- Java
- C
- Microsoft Office
- Unix
- C++
- Crystal Reports
- Sdlc
- Oracle
- Requirements Analysis
- Validation
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