Assoc Product Release Analyst
7 meses atrás
**Assoc Product Release Analyst - Analista de Liberação**
**Atividades**
- Revisar e auditar os dados e registros (batch record) gerados pela Produção no processamento de um lote de material ou produto.
- Certificar-se de que quaisquer erros de batch record sejam corrigidos, todos os componentes de batch record estejam presentes e as investigações sejam referenciadas e aprovadas.
- Emissão da documentação de batch record de Manipulação.
- Revisão dos procedimentos da área de Liberação de Produtos.
- Garantir que as metas de qualidade do site sejam atendidas e que todas as práticas e procedimentos estejam em conformidade com as políticas da empresa e os regulamentos aplicáveis.
- Desenvolver e implementar melhorias de processo para melhorar a conformidade e/ou eficiências.
- Garantir que os batch records sejam retidos e arquivados com segurança
- Liderar atividades de investigação de desvios identificados nas linhas de produção e coordenar a implementação de ações identificadas, tais como amostragens.
- Comunicação e interação diária com Controle de Qualidade, Planejamento e Supply Chain para elaboração de cronograma de liberação, acompanhamento de análises e priorização de atividades. Comunicar o progresso ou atrasos na liberação do lote para as equipes de Planejamento e Supply Chain.
- Gerenciamento de métricas de qualidade relacionadas às atividades de Liberação de Produtos.
- Realizar liberação/rejeição final de produtos no sistema SAP e bloquear lotes de produtos envolvidos em investigações.
- Participar de conferences globais representando a área de Liberação de Produtos e Qualidade do site de Guarulhos, buscando alinhamento de nossas práticas com os padrões corporativos.
**Requisitos**
- Ensino superior completo em Farmácia
- Mínimo de 2 anos de experiência em Indústria farmacêutica em áreas como Produção, Garantia da Qualidade, Controle de Qualidade ou Tecnologia Farmacêutica/Validação
- Conhecimento dos regulamentos e padrões GMP que afetam produtos farmacêuticos
- Boas habilidades de comunicação verbal e escrita
- Habilidades analíticas demonstradas e atenção aos detalhes
- Boas habilidades de relacionamento/comunicação interpessoal
- Inglês Avançado
- Desejável experiência prévia em Liberação de Produtos
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