Tejas Bhat

Background

About Tejas Bhat

I help life sciences and healthcare companies stay compliant and audit-ready—without letting technology slow them down. With 10+ years of experience in Computer System Validation (CSV) and Quality Assurance, I’ve led projects that passed FDA and EU inspections with zero critical findings and even supported faster product launches. I’m passionate about turning compliance into a business advantage. For me, validation isn’t just a regulatory requirement—it’s a way to strengthen quality, speed up delivery, and build trust. A Few Highlights Delivered multiple global CSV projects with zero audit observations Reduced product launch timelines by streamlining validation/testing for a drug distribution platform Improved defect detection to 95% before release, ensuring compliance stays rock-solid Strengthened data integrity through SAP validations and infrastructure qualifications for data centres What I Do Best Translate complex compliance standards (21 CFR Part 11, EU Annex 11, GAMP5, GxP) into clear, actionable validation strategies Build and execute deliverables: URS, FRS, FRA, VMP, IQ/OQ/PQ, Gap Assesment document, mitigation plans, RTM, VSR Lead risk assessments, change controls, deviations, and CAPAs Use tools like JIRA, ServiceNow, SQL, and Veeva to keep validation activities traceable, efficient, and inspection-ready Partner with cross-functional teams so compliance becomes a business enabler—not a bottleneck My Toolkit Compliance & Validation: CSV, GAMP5, Data Integrity, GxP, Audit Readiness Quality & Regulatory: QMS, CAPA, Deviation/Change Control, SOPs, Documentation Technical & Tools: JIRA, ServiceNow, SQL, HP ALM, Veeva, Agile & Waterfall I’m always happy to connect and talk about validation leadership, compliance strategies, or quality-driven digital transformation. Feel free to reach out on: Email: bhatvtejas@gmail.com |+91-9145190019 | DM me here on LinkedIn I am available and open to collaborating with you to work toward a resolution