Senior Quality Assurance Analyst

3 semanas atrás

Itapecerica Da Serra, 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 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 andreceiving 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 collectionand 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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