Marangelli Roman Villabol

Professional with nineteen (19) years of experience in Medical Device and Pharmaceutical Industry, QMS and Engineering areas. Vast leadership experience in FDA and other agency inspections or audits. Experience in product complaints investigations. Experience in the coordination and supervision of the Inspection Readiness activities. Experience on validations documentation development, validation execution and validation review. Responsible for the preparation of the Annual Product Review, trainings new hires and develop, modify and implementation of procedures. Experience in Quality Systems areas. Knowledge in regulations such as: cGMP’s, 21CFR Part 210/211, 820 and ISO 13485. Experienced in conducting investigations and generating investigations reports (NCR, CAPAs, SCARs and Complaints). Experienced in the manage and investigations of Corrective and Preventive Actions (CAPA), Medical Device Reportable evaluation events and Internal Audit manage. Knowledge in preparation of graphs/metrics and statistical analysis. Experience in decommissioning activities and processes. Experience in the preparation of batch record documentation. Good laboratory practices and use of scientific instruments/specialized equipment (e.g. Microscopes and Analytical Balances). Cooperative, fast learner and teamwork oriented. Ability to perform multiple tasks under pressure with minimum supervision. Strong computer skills such as: Minitab, Microsoft Office (Word, Excel, Power Point), cPDM (Collaborative Product Definition Management), NetRegulus, Salesforce, QT9 Management Software and JDEdwards. Good written and oral communications skills in English and Spanish.