Job Summary: Experienced professional to manage technology transfer, optimize production processes, and ensure regulatory compliance, with a focus on quality and continuous improvement. Key Highlights: 1. Technology transfer project management 2. Optimization and continuous improvement of production processes 3. Planning and execution of validation studies Description: * Bachelor's degree in Pharmacy, Chemistry, or Chemical Engineering; * Solid knowledge of quality standards; * Knowledge of quality tools and techniques; * Advanced Office Suite proficiency; * Intermediate English. * Lead and manage technology transfer projects between manufacturing units and/or third parties, ensuring correct transition of production processes. * Develop, review, and approve technology transfer protocols and reports aligned with regulatory requirements and Good Manufacturing Practices (GMP). * Optimize and continuously improve production processes by identifying opportunities for efficiency gains, quality improvements, and cost reduction. * Plan and execute process, cleaning, and system validation studies, ensuring robustness, reproducibility, and regulatory compliance. * Develop and oversee qualification protocols for equipment, utilities, and facilities, ensuring compliance with national and international standards. * Participate in deviation and non-conformance investigations, proposing corrective and preventive actions (CAPA) aimed at process improvement. * Provide technical support to Production, Quality, Engineering, and R\&D departments, ensuring effective and integrated solutions. * Prepare and review technical documentation related to processes, validations, and transfers, ensuring data integrity and traceability. * Collaborate with Regulatory Affairs to provide technical information for submissions and renewals of registrations with competent authorities. * Coordinate technical training on new processes, validation methodologies, and continuous improvement tools. * Conduct risk analyses to mitigate failures in production and validation processes. * Interact with suppliers and external partners to align technical and regulatory expectations during process transfers. 2510310202231779620
João Silva
Indeed · HR
João Silva
Indeed · HR
