Cqv Engineer
Caderno Nacional
Cqv Engineer - Detalhes da Vaga. ● A posição é 100% remota no Brasil, com interação diária com equipes globais e participação em projetos de alta complexidade para um cliente em forte expansão. ●Principais responsabilidades :- Elaborar e executar protocolos de IQ, OQ e PQ para equipamentos, utilidades e sistemas. ●- Desenvolver documentação de qualificação e validação (protocolos, relatórios, análise de riscos e rastreabilidade). ●- Atuar em conjunto com Engenharia, Qualidade, Produção e Validação para garantir a conformidade dos projetos. ●- Apoiar investigações de desvios, CAPAs e atividades relacionadas à conformidade regulatória. ●- Garantir o atendimento aos requisitos de GMP, GAMP 5 e demais normas aplicáveis. ●- Participar de reuniões técnicas com equipes internacionais em inglês. ●Requisitos :- Mínimo de 5 anos de experiência em CQV na indústria farmacêutica, biotecnológica ou de dispositivos médicos. ●- Experiência prática na elaboração e execução de protocolos IQ, OQ e PQ. ●- Conhecimento de GMP, GAMP 5, 21 CFR Part 11 e/ou EU Annex 11. ●- Inglês fluente (obrigatório). ●- Português fluente (obrigatório). ●- Excelente comunicação e capacidade de trabalhar de forma autônoma em ambiente remoto. ●Diferenciais :- Experiência com utilidades críticas (HVAC, PW, WFI, Clean Steam, ar comprimido etc. ●). ●- Conhecimento em CSV/CSA. ●- Experiência em projetos de biotecnologia, vacinas ou produtos estéreis. ●- Vivência em projetos internacionais. ●O que oferecemos :- ?? Trabalho 100% remoto no Brasil. ●- ?? Projeto internacional com contato diário com equipes globais. ●- ?? Acesso a treinamentos técnicos e desenvolvimento contínuo. ●- ?? Reais oportunidades de crescimento dentro de uma empresa em forte expansão. ●- ?? Ambiente colaborativo e exposição a projetos de alta complexidade no setor de Life Sciences. ●?? Se você possui experiência em CQV e fala inglês fluentemente, entre em contato por mensagem privada ou candidate-se à vaga. ●. Requisitos para participar do processo. ● . O que oferecemos.
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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Caderno Nacional
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$ 3.000
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