Dinesh Yadav

About Dinesh Yadav

I always prefer to work in group and my potential supportive nature is one of my strongest power. I have 5+ years of experience as a Quality and Validation Engineer with extensive knowledge of Computer System Validation in FDA compliance and regulations. On projects that I got assigned, I work well to inspire diverse team members and work side by side with them to achieve the project goals. I like to work under pressure, challenge myself, and I have never missed the deadline. I can think any given situation from multiple perspectives, which makes me uniquely qualified to complete my work even under challenging conditions. That issues fixing allows me to be a better team member and feel easy to communicate with team members. I think my ability to see all sides of an issue will make me a great asset to the team.Skills- Data Integrity & Remediation- DI Gap Assessment through Data Process Mapping- Remediate the Identified Gaps- ALCOA+ principle- Post Market Surveillance- Risk Assessment & Mitigation- Risk based approach, GAMP5- pFMEA, DFMEA, FMEA- FDA 21 CFR Part 820, part 11, 210, 211 & Annex 11- GXP, cGMP, GCP, GLP & GDP- ISO 13485, ISO 14971, ISO 9001- VP & VMP- SOPs, URSs, FRSs- IQ, OQ, PQ, UAT, Traceability Matrix, VSR- Test Scripts writing & execution- Periodic Review- Software QA & QC- Experience in Software Development Life Cycle.

Experience

1. Computer System Validation Engineer

   Lonza

   Jan 2023 — Present · Portsmouth, NH, US

Education

• Purbanchal University

  Master of Business Administration - MBA

  2012 — 2014

• Tribhuvan University, IOE, Pulchowk Campus

  Bachelor's degree

  2006 — 2011