Sant Sah
Senior Validation Engineer
- Role
- Senior Validation Engineer at Smith Nephew
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Sant Sah
An expert with 7+ years of experience in the Medical Device and Pharmaceutical industry with proficiency in Validation/QA/QC and Testing in compliance with FDA standards. Thorough understanding of Title 21 CFR Part 11 (Electronic Records/Electronic Signatures), Annex 11, GAMP5, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820. Expertise working in a GXP, cGMP, GLP, GCP, and GDP environment.
Experience
Senior Validation Engineer
Nov 2020 — Present
Identify, analyze, mitigate, and track software risks using risk management tools such as failure mode and effects analysis (FMEAs). Review and approve pre-execution and post-execution of protocols and document test results in test summary reports
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