Products and Features Brasil · São José do Rio Preto, SP, BR
**Descrição e Responsabilidades:** **Horário:** De segunda à sexta, das 8h às 17h 48min com 1h de almoço. **Nível:** Profissional **Regime de contratação:** Efetivo – CLT Act as a technical reference in Microbiology, ensuring appropriate microbiological control of products, raw materials, processes, and environments through the technical evaluation of methods, results, trends, and microbiological risks. Develop, evaluate, and improve microbiological methods and controls; support investigations and validation and qualification activities, including sterilization processes; and provide technical support to Quality, Manufacturing, Engineering, Research and Development, and Regulatory Affairs functions. Contribute to maintaining compliance with Quality Management System requirements, applicable standards, and regulations, promoting process robustness, contamination prevention, and the continuous improvement of microbiological controls. 1\. Manage microbiological activities from a technical perspective * Technically coordinate activities performed by contracted laboratories, ensuring compliance with applicable requirements. * Evaluate microbiological results, trends, and deviations, identifying potential risks. * Plan and monitor microbiological activities according to business needs and quality requirements. 2\. Ensure microbiological control of products and processes * Evaluate microbiological risks related to products, raw materials, processes, water systems, and environments. * Define and improve applicable microbiological controls, acceptance criteria, and specifications. * Monitor microbiological trends and recommend actions to maintain the state of control. 3\. Develop, verify, and validate microbiological methods * Develop, verify, validate, and technically evaluate microbiological methods. * Prepare and review protocols, reports, and technical documentation related to microbiological methods. * Evaluate the suitability of methods used by contracted laboratories. 4\. Investigate microbiological deviations and nonconformities * Provide technical leadership for investigations of deviations, atypical results, OOS, and contamination events. * Conduct root cause analyses and risk assessments, recommending corrective and preventive actions. 5\. Support process validation, qualification, and improvement * Provide microbiology expertise for the validation and qualification of processes, cleaning, sterilization, water systems, and environmental monitoring. * Define or review microbiological sampling plans, methods, and acceptance criteria. * Identify opportunities to improve microbiological methods, controls, and processes. 6\. Ensure compliance with quality and regulatory requirements * Ensure microbiological activities comply with internal procedures, Quality Management System requirements, applicable standards, and regulations. * Provide technical support for audits and inspections, ensuring the availability and integrity of supporting evidence and records. * Evaluate and support the implementation of changes to applicable technical and regulatory requirements. 7\. Technically manage contracted laboratories * Define technical requirements for the contracting and execution of microbiological testing services. * Technically evaluate methods, results, protocols, and reports issued by contracted laboratories. * Support the qualification, performance evaluation, and ongoing monitoring of contracted laboratories. 8\. Promote technical development and continuous improvement * Identify and implement opportunities to improve microbiological methods, controls, and practices. * Evaluate new technologies and methodologies applicable to microbiological control. * Share knowledge and provide technical guidance to relevant teams. Atuar como referência técnica em Microbiologia, assegurando o adequado controle microbiológico de produtos, matérias\-primas, processos e ambientes, por meio da avaliação técnica de métodos, resultados, tendências e riscos microbiológicos. Desenvolver, avaliar e aprimorar métodos e controles microbiológicos, apoiar investigações e atividades de validação e qualificação, incluindo processos de esterilização, e fornecer suporte técnico às áreas de Qualidade, Produção, Engenharia, Pesquisa e Desenvolvimento e Assuntos Regulatórios. Contribuir para a manutenção da conformidade com os requisitos do Sistema de Gestão da Qualidade, normas e regulamentações aplicáveis, promovendo a robustez dos processos, a prevenção de contaminações e a melhoria contínua dos controles microbiológicos. 1\. Gerenciar tecnicamente as atividades microbiológicas * Coordenar tecnicamente as atividades realizadas por laboratórios contratados, assegurando o cumprimento dos requisitos aplicáveis. * Avaliar resultados, tendências e desvios microbiológicos, identificando potenciais riscos. * Planejar e acompanhar as atividades microbiológicas conforme as necessidades do negócio e requisitos de qualidade. 2\. Assegurar o controle micr