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Senior Quality Assurance Analyst...

Senior Quality Assurance Analyst...

CiplaVargem Grande Paulista, São Paulo, BR
Há 17 dias
Descrição da vaga

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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    Quality Assurance Analyst • Vargem Grande Paulista, São Paulo, BR

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