Skills
Computer System Validation (CSV), Regulatory Compliance, 21 CFR Part 11, GxP Regulations, Risk Assessment, Validation Master Plans, Qualification Protocols, Infrastructure Qualification, Cybersecurity, Electronic Data Collection, ALCOA Principles, Data Integrity, Requirements Traceability Matrix (RTM), Test Strategy Development, Test Plan Creation, Test Script Writing, IQ/OQ/PQ Protocols, UAT Execution, Defect Management, Change Control, Process Improvement, SDLC, Regulatory IT, Server Qualification, Database Qualification, BMS, SCADA, DeltaV, MES, EHS, EMS, CMS, Documentum, LIMS, TrackWise, Web Applications, CAPA, Deviation Reports, SOP Development, Gap Analysis, Remediation Planning, Project Management, Cross-Functional Collaboration, Quality Metrics, Status Reporting, Vendor Management, Microsoft Word, Microsoft Excel, Google Analytics.
About
With over nine years of experience in Computer System Validation (CSV), automation, and IT quality assurance within the pharmaceutical industry, I have developed a comprehensive understanding of regulatory compliance and validation processes. My expertise includes documenting, reviewing, and approving key deliverables such as regulatory assessments, risk assessments, validation master plans, qualification protocols, and user/functional specifications. I have successfully validated a wide range of systems, including Infrastructure systems, BMS, SCADA, DeltaV, MES, EHS, EMS, CMS, Documentum, LIMS, TrackWise, and Web Applications. My proficiency extends to regulatory IT and cybersecurity activities, as well as electronic data collection processes.
I have a strong background in representing CSV in infrastructure change controls, requirements trace matrices, and qualification summary reports. My knowledge of 21 CFR parts 11, 820, 203, 208, and 211, along with SDLC activities, has been instrumental in ensuring compliance with regulatory standards. I am experienced in providing status reports and quality metrics to management, maintaining data integrity through ALCOA principles, and leading infrastructure qualifications for servers, databases, and gold images. Additionally, I have a proven track record of conducting regulatory requirement analysis, reviewing and authoring IQ, OQ, and PQ protocols, and preparing test strategies, plans, and scripts in accordance with regulatory guidelines.
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