Senior Quality Assurance Analyst

Há 11 horas

Vargem Grande Paulista, Brasil Cipla Tempo inteiro R$70.000 - R$120.000 por ano

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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