Senior Quality Assurance Analyst

Há 3 dias

Ituiutaba, Brasil Cipla Tempo inteiro

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 DocumentationOutros 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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