Description
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Process, Quality Control, and Process Control * Experience in FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, cGMP Audits, MPR's, SOP's, 21 CFR Part 11, 211, and 820 * Audit Process Validation and manufacturing activities against FDA compliance and 21CFR part 820.
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