Quality Control Manager
3 semanas atrás
Estamos a recrutar um(a) Quality Control Manager para realização de projeto na região de Lisboa.
O(a) profissional será responsável pelas seguintes tarefas:
- Gerir todas as atividades relacionadas com o Controlo de Qualidade (laboratório de Química Analitica GMP, incluindo amostragem, testes e preparação de certificado de análise).
- Garantir a adesão estrita às diretrizes GMP, padrões ISO e outros requisitos regulamentares aplicáveis.
- Desenvolver, implementar e monitorizar protocolos, procedimentos e métodos de teste de CQ.
- Supervisionar e treinar a equipa de CQ.
- Supervisionar as operações do laboratório, incluindo calibração, manutenção e qualificação de equipamentos.
- Conduzir investigações para resultados Fora de Especificação (OOS).
- Colaborar com a equipa de Garantia de Qualidade em CAPAs, desvios e iniciativas de melhoria contínua.
- Preparar e rever a documentação de CQ, incluindo SOPs, relatórios de teste e relatórios de validação.
- Estabelecer ligação com auditores externos e autoridades reguladoras durante as inspeções.
- Manter-se atualizado sobre avanços nas técnicas analíticas e alterações regulamentares relevantes para o laboratório.
Qualificações
Para esta vaga, procuramos um profissional com o seguinte perfil:
- Licenciatura ou Mestrado em Ciências Farmacêuticas, Química, Bioquímica.
- Mínimo de 3 anos de experiência num ambiente de laboratório de controlo de qualidade com licença GMP Domínio de técnicas de química analítica, Cromatografia Líquida, análises de pesticidas e utilização de Sistemas de Dados de Cromatografia é valorizada.
- Forte conhecimento dos requisitos GMP, diretrizes ICH e outros requisitos regulamentares (por exemplo, normas FDA, EMA, ISO).
- Excelentes capacidades de liderança e comunicação.
- Capacidade de trabalhar sob pressão e cumprir prazos rigorosos.
- Fortes capacidades de resolução de problemas e de tomada de decisões.
Informação adicional
Valorizamos um profissional com o seguinte perfil:
- Conhecimentos de MS Office;
- Bons conhecimentos de Inglês;
- Facilidade em comunicar, com gosto pelo trabalho em equipa;
- Flexibilidade de horário;
- Carta de condução;
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