Experienced Computer System Validation professional with a proven track record of ensuring compliance with global and local company policies, procedures, and legal requirements for clinical trials. Adept at applying GxP practices, GAMP categories, and following 21 CFR Part 11 FDA regulations for electronic records and electronic signatures. Skilled in executing all phases of computer system validation for production, QC lab, MO lab, and AR lab systems, including data integrity verification, compliance analysis, risk assessment, and preparation of technical and GMP-related documentation. Proficient in validating MES systems, DCS systems, Excel spreadsheets, and executing NPI activities. Experienced in using Kneat, AGILE DMS, and JIRA validation software to create and execute test plans in the medical device industry.
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Menlo Park, CA, USA
September 1998 - Today 25 years
If I had to sum up my life up to this point, I'd say it's been one heck of a ride...