Qc - Manager

Msn Laboratories; Itapecerica da Serra; Presencial; BRL 300 000 - 600 000; Tempo integral

Resumo da oferta

A Msn Laboratories está buscando um gerente sênior de QC para supervisionar todas as atividades analíticas, assegurando conformidade com GMP, GLP e normas ANVISA RDC no laboratório, mantendo prontidão para inspeções. O profissional liderará transferências de métodos, gerenciará equipamentos e reagentes, e dirigirá o programa de qualidade, incluindo CAPA, OOS e auditorias internas/externas.

Experience de 5–15 anos em QC requerido, com habilidades de gestão, planejamento orçamentário e colaboração

Qualificações

• Experiência comprovada em QC com foco em conformidade com GMP/GLP e ANVISA RDC
• Capacidade de liderar equipes e gerenciar KPIs de qualidade
• Experiência em auditorias internas e externas e resposta a não conformidades

Responsabilidades

• Supervisionar atividades de testes analíticos para assegurar conformidade com GMP/GLP, ANVISA RDC e requisitos regulatórios.
• Gerenciar transferência de métodos com R&D, manufatura e contratados terceiros.
• Conduzir liberação de resultados analíticos dentro dos prazos com padrões de qualidade.
• Gerenciar aquisição, qualificação, calibração e manutenção de equipamentos de QC.
• Supervisionar gestão de reagentes e padrões de referência, do fornecimento à disposição.
• Estabelecer e manter sistemas de qualidade no QC, incluindo OOS/Deviations, CAPA e change control, gestão de risco.
• Prever e gerenciar orçamento do departamento, incluindo pessoal, equipamentos e serviços externos.
• Desenvolver visão estratégica e planos operacionais para o QC alinhados aos objetivos da empresa

Conhecimentos

GMP/GLP knowledge

ANVISA RDC awareness

Quality systems and audits

CAPA and deviation handling

Regulatory audits

Descrição da oferta de emprego

Descrição da vaga

• Oversee all analytical testing activities to ensure compliance with GMP, GLP, ANVISA RDC, and other applicable regulatory requirements, ensuring data integrity, accuracy, and traceability throughout all operations, maintaining the laboratory in a state of inspection readiness.
• Ensure robust method transfer processes are in place and executed effectively, collaborating closely with R&D, manufacturing, and third-party contractors.
• Drive the timely release of analytical results within schedules while maintaining stringent quality standards.
• Manage the acquisition, qualification, calibration, and maintenance of all QC laboratory equipment and instrumentation.
• Oversee the entire process for chemicals, reagents, and reference standards management, from procurement to disposal, ensuring supply chain integrity and compliance.
• Establish and maintain robust quality systems within QC, including OOS/Deviation management, CAPA effectiveness, change control, and risk management. Provide strategic direction for complex method troubleshooting, OOS investigations and other quality related process.
• Forecast and manage the departmental budget, including staffing, equipment, consumables, and external services.
• Develop and implement the strategic vision and operational plans for the QC department,

  aligning with the company overall business objectives and quality goals.

  • Actively participate in internal and external regulatory audits (e.G., ANVISA, client audits), providing expert responses and presenting laboratory data and processes.
  • Act as a primary point of contact and subject matter expert for all QC-related discussions during internal and external audits. Lead the preparation and response to audit findings, ensuring timely and effective CAPA implementation and closure.
  • Stay abreast of new and evolving pharmaceutical regulations and industry best practices, ensuring the QC department remains fully compliant.
  • Establish and monitor departmental Key Performance Indicators (KPIs) to drive efficiency, compliance, and quality improvements.
  • Oversee recruitment, training, performance management, and career development for all QC personnel.
• Ensure adequate staffing levels and competencies to meet operational demands and future growth.
• Conduct performance reviews, provide constructive feedback, identify training needs, and support the professional development of team members.
• Promote a strong safety, continuous improvement and proactive problem-solving culture within the laboratory, ensuring all team members adhere to EHS policies and procedures.
• Collaborate effectively with other departments such as Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Supply Chain, and Project Management to ensure seamless operations and achieve company goals.
• Participate in management review meetings, product development teams, and other cross-functional committees as required.

Experience- 5 to 15 Years