Quality Assurance Technician

2 semanas atrás

AlbergariaaVelha, Portugal Indigo Horizon Tempo inteiro

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.

Management of corrective and preventive actions in the scope of GACP, GMP, GDP and QMS

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.

Working according to deadlines for the delivery of products

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
- __________________________

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.

Avaliar/aprovar a limpeza do equipamento e da área de produção com protocolos e relatórios de qualificação

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).

Gestão de acções correctivas e preventivas no âmbito das GACP, GMP, GDP e QMS

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.

Trabalhar de acordo com os prazos de entrega dos produtos

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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