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San Francisco Bay Area United States

Validation Consultant at ALKU - Thermo Fisher Scientific

Medical / Health Care / Pharmaceuticals

Core competencies: • 14 years experience in the medical device industry as a subject matter expert in software validation • Experience in FDA 483 Observation, FDA Consent Decree and FDA audits • In-depth knowledge of 21 CFR Part 820 Quality System Regulation, ISO 9001 & 13485, 21CFR Part 11 (Electronic Records & Signature), GAMP 4 & GAMP 5 * Experience in developing software validation plan, system classification, risk analysis, user requirements, functional design requirements, IQ, OQ, and PQ protocols, traceability matrix, SOP, qualification summary report, and validation summary report • Experience also design control, change and configuration management • Software Develop