al.• ï· Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports.• ï· Analyze and summarize data for validations, CAPA, and Comar “TPI3” CI initiatives.• ï· Internal Auditing of adherence to procedures.• ï· Manage the Visual Factory Layered Process Audit process and report out on deficiencies and• actions.• ï· Monitor impact of plant-floor, process or setting changes on the validated state of the lines.• ï· Create, modify, and approve (with other SMEs) deviations and change control requests for• documents, equipment, and processes.• ï· Track open deviations and change controls for proper closure and resolution. Determine• corrections, corrective actions, and verification of effectiveness.• ï· Analyze data and trends within the CAPA process to determine systemic risks.• ï· Lead corrective action effort for systemic risks.• ï· Document investigations and improvements using analysis of data (ANOVA, Cpk, Trending, etc.)• ï· Identifying opportunities for Continuous Improvement, defining value and implementation.