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Quality Assurance Technician
2 semanas atrás
The Quality Assurance Technician is responsible for building, implementing, and maintaining quality assurance systems and processes that comply with GACP and GMP requirements.
This individual will oversee and execute all aspects of the Quality Department and interface with internal teams, clients, regulators, and other third parties.
Responsibilities
Work closely with production teams to ensure compliance with regulations and quality standards.
Evaluate/approve equipment and production area cleaning with qualification protocols and reports
Develop and implement QA/QC procedures and processes to ensure consistent product quality.
Maintain accurate records of all quality control and quality assurance checks and results, under Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) guidelines.
Batch documentation review
Inspect raw materials, in process materials, and final product
Report to management on the performance of the QMS (e.g., results of quality audits, corrective actions,) including the need for improvement.
Ensure all audit responses are closed out in a proper and timely manner
Training and managing production staff in best practices and quality assessment of goods
Stay up-to-date with industry trends, regulations, and best industry practices
Required:
Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering or similar discipline
2+ years experience in quality assurance / quality control programs
Direct knowledge of GMP regulations and guidelines.
Experience with qualifications, validations and risk evaluations for manufacturing.
Experience with compliance management including interfacing with regulators and inspectors.
Detail Oriented
Fluent in English
Preferred
Familiarity with Cannabis Production and regulation GAP / GACP / or Control Union
A minimum of 2 years in a team management role
Effectively communicate technical information to technical and non-technical audiences
Experienced with electronic document management and inventory management systems
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O Técnico de Garantia de Qualidade é responsável pela criação, implementação e manutenção de sistemas e processos de garantia de qualidade que cumprem os requisitos GACP e GMP.
Este indivíduo irá supervisionar e executar todos os aspectos do Departamento de Qualidade e interagir com equipas internas, clientes, reguladores e outros terceiros.
Responsabilidades
Trabalhar em estreita colaboração com as equipas de produção para garantir o cumprimento da regulamentação e das normas de qualidade.
Desenvolver e implementar procedimentos e processos de QA/QC para garantir a qualidade consistente dos produtos.
Manter registos precisos de todas as verificações e resultados do controlo de qualidade e da garantia de qualidade, de acordo com as orientações das Boas Práticas Agrícolas e de Colheita (BPCC) e das Boas Práticas de Fabrico (BPF).
Revisão da documentação do lote
Inspecionar as matérias-primas, os materiais em processamento e o produto final
Informar a administração sobre o desempenho do SGQ (por exemplo, resultados de auditorias de qualidade, acções correctivas), incluindo a necessidade de melhorias.
Assegurar que todas as respostas às auditorias são encerradas de forma correcta e atempada
Formação e gestão do pessoal de produção em matéria de boas práticas e de avaliação da qualidade das mercadorias
Manter-se atualizado sobre as tendências, regulamentos e melhores práticas do sector
Necessário:
Licenciatura em Ciências Farmacêuticas, Química, Engenharia Química ou disciplina similar
Mais de 2 anos de experiência em programas de garantia de qualidade / controlo de qualidade
Conhecimento direto dos regulamentos e orientações das BPF.
Experiência em qualificações, validações e avaliações de risco para o fabrico.
Experiência na gestão da conformidade, incluindo a interface com reguladores e inspectores.
Orientado para os pormenores
Fluente em inglês
Preferenciais
Familiaridade com a produção de cannabis e com a regulamentação GAP / GACP / ou União de Controlo
Um mínimo de 2 anos em funções de gestão de equipas
Comunicar eficazmente informações técnicas a audiências técnicas e não técnicas
Experiência com sistemas electrónicos de gestão de documentos e de gestão de inventário
Tipo de oferta:
Período Integral
Benefícios:
- Horário flexível
Horário de trabalho:
- Horário flexível
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