Gisela Paone Email & Phone Number

Aseguramiento De La Calidad

Aseguramiento De La Calidad

Generation of validation, procedure, approval of qualification procedure and equipment and software validation.Development, Execution, Review and approval of documentation required for computer system according to GAMP 5 (SDLC), Data integrity y corporate requirements . (as RS,QAP, RTM SC, UAT QARS)Issuance, Review and approval of validation document from other areas (Packaging, Engineering, Quality Control y Biotechnology)Leadership in project that requires validation process… Show more Generation of validation, procedure, approval of qualification procedure and equipment and software validation.Development, Execution, Review and approval of documentation required for computer system according to GAMP 5 (SDLC), Data integrity y corporate requirements . (as RS,QAP, RTM SC, UAT QARS)Issuance, Review and approval of validation document from other areas (Packaging, Engineering, Quality Control y Biotechnology)Leadership in project that requires validation process (incorporation of new software, new equipment, areas modification, Data Integrity, Modernization y quality control IPI)Change Control Administration and management (Trained in United States)SPS in TackwiseMonitoring of maintenance and qualification Budget of laboratory equipmentSupervision of maintenance and qualification area of laboratory equipment, ensuring compliance on local, corporates regulation requirements of safety.Active participation in Internal AuditsDevelopment of product release process tasks (preparation of 15-point forms, presentation to Iname of products to be released, review of COAs (quality of origin certificates)Issuance and review of laboratory diversions, equipment and supplier claims for services qualificationIssuance and monitoring of CAPAs (corrective actions and preventive actions).Have staff in chargeUsing MPS, Kaizen and 5S tools. (Trained by MSD Global).Tracking in profit plan, generation and/or approval of purchase orders in the SAP system. Show less

Laboratorio De Desarrollo Global

Issuance Master Control Procedure for Europa, Japan, EEUU, also issuance of procedure of laboratory software validation and laboratory with GAMP requirements. Responsible of equipment calibration and maintenanceManagement Change Control and Deviation. Participation in Internal Audits.Analysis and Stability of new product for FDA, Japan and EuropeAnalista de desarrollo de productos global, analista de estabilidades global y validaciones. Realice validación de nuevos… Show more Issuance Master Control Procedure for Europa, Japan, EEUU, also issuance of procedure of laboratory software validation and laboratory with GAMP requirements. Responsible of equipment calibration and maintenanceManagement Change Control and Deviation. Participation in Internal Audits.Analysis and Stability of new product for FDA, Japan and EuropeAnalista de desarrollo de productos global, analista de estabilidades global y validaciones. Realice validación de nuevos productos apara exportar al exterior, analice estabilidades de productos que se exportaba a Europa, japón etc. Tenia a cargo la gestión de calibración, calificación y mantenimiento preventivo de todos los equipos de laboratorio.Debe contactar al proveedor para realizar las tareas correspondiente a las frecuencia establecidas en los procedimientos. También actualizaba los procedimientos. Pasamos auditoria EMEA y FDA. Show less