Senior Quality Assurance Analyst
Há 24 horas
DESCRIÇÃO DE CARGO DE ANALISTA DE GARANTIA DA QUALIDADE SÊNIOR (OOS / DOCUMENTAÇÃO ANALÍTICA)
JOB DESCRIPTION SENIOR QUALITY ASSURANCE ANALYST (OOS / ANALYTICAL DOCUMENTATION)
Requisitos Técnicos – Formação / Technical Requirements / Training:
•Superior em Farmácia, Biologia, Química, Engenharia Química, Bioquímica.
Degree in Pharmacy, Biology, Chemistry, Chemical Engineering, Biochemistry.
Conhecimentos / Knowledge:
• Noções Avançadas de Garantia da Qualidade; Advanced Notions of Quality Assurance
• Noções Avançadas de Documentação técnica; Advanced Notions of Technical Documentation;
• Noções de Controle de Qualidade e Validação Analítica; Basic knowledge of Quality Control and Analytical Validation;
Experiência / Experience:
•Experiencia comprovada em Indústria Farmacêutica ou Distribuidoras ou Farmácias;
Proven experience in the Pharmaceutical Industry or Distributors or Pharmacies;
•Experiência com Documentação de Validação Analítica;
Experience with Analytical Validation Documentation
Outros Conhecimentos / Other Knowledge:
•Inglês: Avançado ou Fluente (Conversação, leitura e escrita);
English: Advanced or Fluent (Conversation, reading and writing);
•Pacote Office: Avançado, com ênfase em Excel e Power Point;
Office Package: Advanced, with emphasis on Excel and Power Point;
Atribuições do Cargo:
•Aprovar procedimentos operacionais (POPs), plano mestre e manuais referentes à área da Garantia da Qualidade e Controle de Qualidade; Approve operational procedures (SOPs), master plans, and manuals related to Quality Assurance and Quality Control areas.
•Elaborar, revisar e aprovar procedimentos operacionais e manuais referentes à Garantia da Qualidade e Controle de Qualidade (quando aplicável); Prepare, review, and approve operational procedures and manuals related to Quality Assurance and Quality Control (when applicable).
•Gerenciamento do envio e recebimento de documentos para empresa terceirizada que realiza tradução (inglês / português e vice-versa); Manage the sending and receiving of documents to/from third-party translation companies (English/Portuguese and vice versa).
•Gerenciamento de coleta de resíduos e assuntos relacionados à questão ambiental (solicitação de empresas fornecedoras de embalagens para coleta de resíduos classe B, elaboração de CADRIs, supervisão de empresas terceiras relacionadas ao gerenciamento ambiental dos resíduos); Manage waste collection and environmental issues (request suppliers for Class B waste collection containers, prepare CADRIs, supervise third-party companies related to environmental management of waste).
•Gerenciamento de licenças (bombeiro, SABESP, IBAMA, etc.) e documentos legais perante os órgãos regulatórios; Manage licenses (fire department, SABESP, IBAMA, etc.) and legal documents with regulatory agencies.
Atualizar e/ou dispor de FISPQ relacionados aos reagentes utilizados na Cipla Brasil; Update and/or provide MSDSs related to reagents used at Cipla Brazil.
•Implementar os procedimentos operacionais e participação do gerenciamento de documentação (elaborar, revisar, implementar, obsoletar); Implement operational procedures and participate in documentation management (prepare, review, implement, obsolete).
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