Alessandra Almeida Email and Phone Number
Providing changes in people and process in the Quality Control field on biopharmaceutical’s industries.Focus on results, process improvement and people's development. Quality Control Coordinator at Instituto Butantan, São Paulo - Brazil.Biological Quality Control and technology transfer of vaccines and biopharmaceuticals management.Implementation and development of biological tests on vaccines and biopharmaceuticals from different technology transfer projects with international partners in the pharmaceutical industry, emphasis on immunobiologicals.Act as coordinator of a team of analysts and Quality Control laboratory technicians in a multi-product environment.Development and validation of alternative methods to replace the use of laboratory animals in viral and bacterial vaccines produced in order to meet the national immunization program.Cell based potency assays of biopharmaceuticals. Biotech and advanced therapies for rare diseases and onco hemathology disease, focused on QC and regulatory compliance.Testing of adventitious agents in viral vaccines (measles, mumps, rubella, chickenpox, yellow fever, rotavirus, COVID, dengue, rabies).Serological control of farms that supply SPF eggs for the production of viral vaccines (measles, mumps and yellow fever).Knowledge in biochemistry, immunology, virology, cell culture, potency and thermostability.Performs standardization and analytical validation of methods, being responsible for the tests carried out in the Biological Quality Control.Solid knowledge of GMP standards, international standards and guides related to the pharmaceutical industry and regulatory matters in the sector and technology transfer.Coordinator of animal experimentation laboratory linked to the quality control board, being responsible for planning, supervision, coordination of activities in the area of experimentation, maintenance and handling of laboratory animalsMaster in Collective Medicine (Fluminense Federal University)Graduated in Veterinary Medicine (UFF)Extracurricular internship at the Department of Immunology and Cell Biology. (University of Sherbrooke, USherbrooke, Canada).
Bio-Manguinhos / Fiocruz
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Manager Of The Biological Control Section In Bio-Manguinhos - Oswaldo Cruz FoudantionBio-Manguinhos / FiocruzSão Paulo, Brazil -
Scientific Advisor In Technology Transfer Project Of Cart Cells And Advanced Therapy ProductsBio-Manguinhos / Fiocruz Feb 2024 - PresentRio De Janeiro, BrasilMonitor discussions for the construction and installation of an aseptic processing module for advanced cell therapy products (Cart cells and viral vectors).Interac with the strategic areas such as enginnering, QA, QC, occupational safety, biosafety, budgetary, managers and key stakeholders of the techonology transfer partner company. Align the schedule for delivered process equipment and standards with the AMTP module’s local execution schedule.Ensure high level GMP overview inside the module.Drive preparation for and follow-up on authority inspections and internal audits. Estabilish high quality standards in the operationalization of the GMP modules.Critically evaluate all the documentation from the partner (process and quality) and adress it to the interlocutors for implementation in the areas. -
Quality Control CoordinatorInstituto Butantan Feb 2022 - Mar 2024São Paulo, BrasilResponsável pela gestão do fluxo de trabalho, capacidade e processos para a execução de testes de controle de qualidade biológica (potência biológica de soros e vacinas,ensaios biomoleculares eimunocitoquímicos, agentes adventícios, identidade, atividade imunogênica, infectividade,imunodifusão em gel de agarose, SDS-page entre outros testes in vivo e in vitro) de vacinas, soroshiperimunes e biofármacos. Facilitadora do Controle da Qualidade nos projetos de transferência detecnologia dos testes de controle de qualidade de vacinas, assegurando atendimento ao cronograma datransferência. Avaliação de documentos do parceiro tecnológico. Elaboração de cronogramas epreenchimento de documentos de importação para atendimento ao projeto de TT. Auxilia nas discussões técnicas entre o parceiro, ANVISA e diretoria. Realiza estudos de adequabilidade e capacidade da planta e de pessoal dos laboratórios para absorção de novas metodologias analíticas vindas da transferência de tecnologia ou de desenvolvimento interno. Responsável pelo planejamento e compra dos materiais de consumo e permanentes do laboratório do Controle de Qualidade. Investigação de resultados fora da especificação e apoio à garantia da qualidade na análise de causa raiz de desvios de qualidade do produto, buscando solucionar problemas ou implementar novas tecnologias. Organização do cronograma dos ensaios visando garantir a entrega dos resultados de acordo com o prazo para atendimento ao Programa Nacional de Vacinação. Avaliação e respostas às exigências da ANVISA. Recebimento de auditorias e visitas técnicas nacionais e internacionais. Responsável pelas respostas durante auditoria para obtenção do CTO e do certificado de pré-qualificação da WHO. Coordenação das etapas de validação de processo, validação analítica, e estudos de estabilidade. Elaboração e revisão de análises de risco e gap analysis; Participação em CMs, avaliação de impacto, desvios e investigações. -
Manager Of The Biological Control Section In Bio-Manguinhos - Oswaldo Cruz FoudantionBio-Manguinhos / Fiocruz -
. Head Of The Biological Control Section Of The Quality Control Department.Bio-Manguinhos / Fiocruz Nov 2010 - Dec 2022Rio De Janeiro, BrasilManager of the biological control laboratory of the vaccine quality control department, developing my activities in this laboratory for 10 years; -
Tecnologista Em Saúde Pública Supervisora Do Laboratório De Experimentação AnimalBio-Manguinhos / Fiocruz Jun 2008 - Oct 2010Rio De Janeiro, Brasil
Alessandra Almeida Education Details
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Imunologia E Biologia Celular -
Community Health And Preventive Medicine -
Veterinary Medicine
Frequently Asked Questions about Alessandra Almeida
What company does Alessandra Almeida work for?
Alessandra Almeida works for Bio-Manguinhos / Fiocruz
What is Alessandra Almeida's role at the current company?
Alessandra Almeida's current role is Manager of the Biological Control Section in Bio-Manguinhos - Oswaldo Cruz Foudantion.
What schools did Alessandra Almeida attend?
Alessandra Almeida attended Université De Sherbrooke, Universidade Federal Fluminense, Universidade Federal Fluminense.
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