Ana Laura Alfano
Jefe de Aseguramiento de la Calidad / QA Lead at ProinPharma Biomed- Claim this Profile
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Bio
Giselle Anahi Pozo
Ana is hard-working. She puts great passion into everything she does and she is deeply comitted to her projects. Although she has great expertise in the medical field, she also has strong business skills. However, the biggest strength Ana possess is being an amazing colleague. She is truly a team player and she has been a pleasure to work with. I have no doubt she will continue to achieve great sucess in her career.
Giselle Rodriguez
Profesional responsable, proactiva, buenas habilidades comunicacionales. Excelente colega. Siempre dispuesta a enseñar y a colaborar.
Giselle Anahi Pozo
Ana is hard-working. She puts great passion into everything she does and she is deeply comitted to her projects. Although she has great expertise in the medical field, she also has strong business skills. However, the biggest strength Ana possess is being an amazing colleague. She is truly a team player and she has been a pleasure to work with. I have no doubt she will continue to achieve great sucess in her career.
Giselle Rodriguez
Profesional responsable, proactiva, buenas habilidades comunicacionales. Excelente colega. Siempre dispuesta a enseñar y a colaborar.
Giselle Anahi Pozo
Ana is hard-working. She puts great passion into everything she does and she is deeply comitted to her projects. Although she has great expertise in the medical field, she also has strong business skills. However, the biggest strength Ana possess is being an amazing colleague. She is truly a team player and she has been a pleasure to work with. I have no doubt she will continue to achieve great sucess in her career.
Giselle Rodriguez
Profesional responsable, proactiva, buenas habilidades comunicacionales. Excelente colega. Siempre dispuesta a enseñar y a colaborar.
Giselle Anahi Pozo
Ana is hard-working. She puts great passion into everything she does and she is deeply comitted to her projects. Although she has great expertise in the medical field, she also has strong business skills. However, the biggest strength Ana possess is being an amazing colleague. She is truly a team player and she has been a pleasure to work with. I have no doubt she will continue to achieve great sucess in her career.
Giselle Rodriguez
Profesional responsable, proactiva, buenas habilidades comunicacionales. Excelente colega. Siempre dispuesta a enseñar y a colaborar.
Experience
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ProinPharma Biomed
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Argentina
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Biotechnology
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1 - 100 Employee
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Jefe de Aseguramiento de la Calidad / QA Lead
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Dec 2021 - Present
Implementación, actualización y gestión del SGC. Capacitación del personal. Aplicación de políticas de calidad. Interpretación e implementación de Buenas Practicas de Manufactura para asegurar la calidad de los productos, procesos documentos e imagen corporativa. Detección y manejo de desvíos de calidad, CAPA. Gestión de Cambios y análisis de riesgo. Interacción con I+D, DT y CC con el fin de potenciar los desarrollos con el fin de cumplir los altos estándares de la regulación local y así alcanzar productos de calidad, seguros y eficaces. Estrategias para la mejora continua de los procesos GxP. Generar el espacio para el mantenimiento y conducción de la política de calidad corporativa. Show less
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Proinvet Innovations S.A.
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Argentina
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Biotechnology
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1 - 100 Employee
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Jefe de Aseguramiento de la Calidad | QA Lead
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Dec 2021 - Present
Implementación, actualización y gestión del SGC. Capacitación del personal. Aplicación de políticas de calidad. Interpretación e implementación de Buenas Practicas de Manufactura para asegurar la calidad de los productos, procesos documentos e imagen corporativa. Detección y manejo de desvíos de calidad, CAPA. Gestión y análisis de riesgo. Coordinación de actividades I+D. Interpretacion de normativas y reglamentaciones. Interacción con Dirección técnica para asegurar la seguridad y eficacia de los productos liberados al mercado así como de la correcta implementación de las buenas prácticas de manufactura durante todo el ciclo productivo. Accionar estrategias para la mejora continua de los procesos GxP. Generar el espacio para el mantenimiento y conducción de la política de calidad corporativa. _______________________________________________________________________________________________________________ Implementation, update and management of the QMS. Staff training. Interpretation and implementation of GxP to ensure the quality of products, processes and documents. Detection and management of quality deviations, CAPA. Quality Risk Management. Coordination of R&D activities. Interpretation of policies and regulations. Ensure the safety and efficacy of marketed products. Ensure implementation of good manufacturing practices throughout the entire production cycle. Be a key player in the implementation of strategies for the continuous improvement of GxP processes. Generate the scene for the maintenance and conduct of the company quality policy. Show less
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Universidad Kennedy
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Argentina
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Higher Education
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100 - 200 Employee
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Profesor Adjunto - Biotecnología Farmacéutica / Higiene y Saneamiento
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Sep 2020 - Present
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Patient Safety Specialist
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Jan 2020 - Dec 2021
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Patient Safety Specialist
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Jul 2019 - Dec 2019
Managed, triggered, processed and conducted follow-up of Individual Safety Case Reports. Ensured compliance with global and local procedures. Submitted safety reports to the Health Authority. Administered and used databases and registries. GxP.Ensured initiatives meet the organization goals and the shared area objectives.
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The Green Genetics
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Argentina
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Biotechnology
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Servicio científico
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Apr 2019 - Sep 2019
Provided support to design PCR protocols. PCR assays. Molecular and Genomics analysis. Provided support to design PCR protocols. PCR assays. Molecular and Genomics analysis.
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Investigador doctoral
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Sep 2014 - May 2019
Laboratorio de Terapia Molecular y Celular Research topics: Oncology, virotherapy, gene therapy, gene engineering, molecular biology, cell biology, stem cells, innovative treatments, gynaecological cancers, biological medical products. General responsibilities: Experiment design and execution. Scientific data communication and discussion. Undertook initiatives in order to achieve research goals. Teamwork. Handling of laboratory instruments. Provided support to the procurement department and other administrative areas. Research goals achievements: Two relevant scientific publications, two oral symposium communications and five poster symposium presentations. Show less
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Universidad Nacional de La Plata
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Argentina
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Higher Education
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700 & Above Employee
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Pasante
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Jun 2013 - Jul 2014
Management of research laboratory use schedules for academic purposes.Handling and maintenance of laboratory instruments.
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Investigador científico Pasantia
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Aug 2012 - Dec 2013
Research topics: Primary mammalian cell culture, Scaffolds, Biocompatibility and citotoxicity studies, Tissue engineering. Experiment design and execution. Scientific data communication and discussion. Undertook initiatives in order to achieve research goals. Teamwork.Handling of laboratory instruments. Provided support to the procurement department and other administrative areas.Research goals achievements: one relevant scientific publications and two poster symposium presentations. Show less
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Education
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Universidad de Buenos Aires
Doctorado, PhD, Farmacia y Bioquímica, Ciencias de la salud -
RocketProgram
Curso de Experto, Clinical Oncology Medical Affairs Experience -
Colegio de Farmacéuticos y Bioquímicos de Capital Federal - COFyBCF
Curso introductorio sobre asuntos regulatorios en productos médicos, Regulatoria, Productos médicos. -
Universidad Kennedy
Farmacéutica, (Universidad Nacional de La Plata 60% de carrera de Farmacia 2008-2010, 2014) -
Universidad Nacional de La Plata
Licenciatura, Biotecnología y Biología Molecular -
SAFYBI - Sociedad Argentina de Farmacia y Bioquímica Industrial
Diplomatura en Aseguramiento de la Calidad en la Industria Farmacéutica, Aseguramiento de la Calidad, QA