Lelis Ivana Alvarez
About
Detail
Farmaceutica | Lead Auditor | Investigacion Clinica | Risk Assessment | Monitor (ICH-GCP) | Quality (GMP-GxP) | Data Integrity
Buenos Aires, Argentina
Résumé
Jobs
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Clinical Research AssociateNovo NordiskMay 2024 - Nov 2025 (1 year 7 months)Clinical Quality Analyst: Management of monthly Clinical Quality KpI, Site Quality Visits based on risk assessment, facilities tour following the participant flow, IMP flow, TMF accuracy and quality data of the site. Follow up and trend analysis of Ethical Monitoring carried out at sites by IECs. Trend analysis of issues comes from quality, coaching and CPM co-visits. Assessment of causality and risk of depot deviation. Clinical Research Associate: Onsite and remote monitoring activities. Confirm informed consent procedures and protocol have been performed in accordance with applicable regulations. Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulation, and SOP- Clinical Research AssociateICON Strategic SolutionsOct 2023 - May 2024 (8 months)Onsite and remote monitoring activities confirm informed consent procedures and protocol have been performed in accordance to applicable regulations. Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs. Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans
- FFarmaceuticaFarmaciaJan 2017 - Current (9 years 6 months)
- Analista Quality ComplianceTakeda PharmaJul 2016 - Oct 2023 (7 years 4 months)Manage of Complaint according to global SOP and recorder in EQMS platform Data Integrity Monitor, giving support in implementation, evaluation of specific equipment, electronic and manual records according to annual CAPA plan. Quality Agreements follow global and suppliers templates (intercompany, raw material, packaging, manufacturing suppliers, warehouse, herbal material) Supplier Qualification according to global SOP (API, Transport, raw material) Alignment of Compliance Global SOPs (LEADs platform) Trainings Selfinspections/ External inspections, support to the global audit team anf accordin to local and global risk assessment CAPAs approver Validation Master Plan/ Site Master File KPI – Quality Metrics (SAP, EQMS)
- Analista de aseguramiento de la calidadLaboratorio Veinfar ICSAMar 2015 - Jul 2016 (1 year 5 months)Medicinal Laboratory of injectable and Betalactamics products in hospital presentation only, own production plant. Manage of Deviation, Complaint, GMP trainings to the plant, Support in Annual plan equipment, Selfinspections and external inspections, Process validations, Validation Master Plan, Redaction and update of SOPs
- AnalistaSandozMay 2012 - Mar 2015 (2 years 11 months)Use of platform Trackwise for Deviation from Argentina, Paraguay, Uruguay and Chile; for Complaint from Argentina, Paraguay, Uruguay y Chile. Batch Records Review through SAP and Trackwise. Responsible for samples retentions. Performance Annual Product Review for products import. Performance of Back Up QC equipment. Internal Quality Agreements.
- analistaAgroinsumosApr 2008 - May 2012 (4 years 2 months)Análisis fisicoquímicos de materias primas, productos terminados y graneles (inyectables, suspensiones y polvos). Búsqueda bibliográfica para desarrollo de técnicas de análisis de materia prima y producto terminado, desarrollo de procedimientos, protocolos de análisis, planillas de control, análisis de testigos. Muestreo. Técnicas empleadas: Volumetrías (iodométricas, acidimétricas, valoraciones heterogéneas, en medio no acuoso, por retorno, potenciometrias, etc.). Valoraciones espectrofotométricas, HPLC , cuantificación de minerales por Absorción Atomica (equipo Variaan), cromatografía en placa delgada (TLC), análisis comunes (descripciones, solubilidades, miscibilidades, perdidas por secado, pH, identificaciones) Equipos empleados: Espect
Education
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- Posgrado en Aseguramiento de la CalidadUniversidad de Ciencias Empresariales y SocialesJan 2020 - Dec 2020 (1 year)
- IPlanning for the implementation of a quality management system IRAM-ISO 9001: 2015IRAMJan 1996 - Dec 2021 (26 years)
- FarmaceuticaUniversidad KennedyJan 1996 - Dec 2001 (6 years)
- FarmaceuticaUniversidad Argentina John F KennedyJan 1996 - Dec 2001 (6 years)
- FMonitor ClinicoFEFyM
- Training in GxP Audits and risk assessmentUBA