Mogi das Cruzes, São Paulo, Brazil
24 years of experience in the Pharmaceutical Industry. Solid knowledge in GMP / GMP, FDA, EMEA, INVIMA; • Leader Audit in cold chain drugs storage and distribution; • Acting as a Coordinator in the areas of production of solid pharmaceutical forms, non-sterile liquids, semi-solids and cosmetics; • Process Validations and Cleaning Validations of solid, liquid, cosmetic and injectable products; • Focal Point to investigate deviations; • Responsible for doing root cause analysis of problems and defining strategic plan and action. • Participation / performance in actions for market complaint; • Evaluation of global guidelines gaps; • Responsible for the implementation / maintenance of the 5S Program in the productive area; • Responsible for the implementation of the Lean Manufacturing program and its tools (Visual Management, SMED, TPM, VSM, 5S and Kaizen) in the productive areas. • Participation in national and international audits (EMEA / INVIMA / CORPORATE) acting as technical presenter of the area and responsible for responding; • Responsible for maintaining the safety indicators in the productive area; • Technology transfer between manufacturing sites and product line extension launch (new packaging and small formulation changes); • Coordination of projects for Qualification of new suppliers of Raw Materials for Pharmaceutical area including API and Excipients, medications distributor, packaging and services providers; • Technical support to the industrial area in maintenance of solid, liquid, semi-solid and injectable products; • Responsible for disseminating the concept of Quality Culture in the company and raising the level of Quality • Racine Institute Professor in Postgraduate Courses and Intensive Courses in the Pharmaceutical Industry
Employees: 42 employers Main activities: • Ensure legal compliance with Good Manufacturing Practice activities; • Ensure control of all technical documentation (master formulas, production and packaging instructions); • Coordination and performance with team training regarding Quality and related issues, procedures, tools, processes and GMP; • Leadership in investigating Quality Deviations from data collection, interviews, preparation of action plans with the areas involved; • Responsible for process inspections to ensure compliance with procedures; • Coordination of anual product reviews; • Creation of inspection routine in productive areas with identification of opportunities for improvement; • Preparation and review of internal procedures; • Implementation of quality indicators with sight management; • Maintenance of area indicators, acting in the achievement of goals. • Planning, implementation and maintenance of the Quality Culture Program in order to disseminate the concept and raise the quality level • Market Claim management
Employees: 5 analysts Main activities: • Ensure legal compliance with Good Manufacturing Practice activities; • Ensure control of all technical documentation (master formulas, production and packaging instructions), manuals (quality and pharmacovigilance) and procedures; • Coordination and performance with team training regarding Quality and related issues, procedures, tools, processes and GMP; • Process Validation Coordination for CPHD, SPPV and SPGV products and Cleaning validations; • Leadership in investigating Quality Deviations from data collection, interviews, preparation of action plans with the areas involved; • Responsible for process inspections and internal audits to ensure compliance with procedures; • Coordination of periodic product reviews; • Creation of inspection routine in productive areas with identification of opportunities for improvement; • Preparation and review of internal procedures; • Approval of final art; • Change control management; • Performance monitoring of suppliers, together with the supply areas; • Coordination, development and approval of suppliers of raw materials, packaging materials and other materials that affect quality assurance; • Implementation of quality indicators with sight management; • Preparation of import, storage and distribution flow of cold chain cancer drugs and distributor audits; • Qualification of suppliers as Lead Auditor; • Participation and execution of actions for dealing with customer service; • Maintenance of area indicators, acting in the achievement of goals. • Planning, implementation and maintenance of the Quality Culture Program in order to disseminate the concept and raise the quality level
Employees: 33 operators Supervision of Production in the area of cosmetics, being responsible for evaluating, planning and monitoring the daily development of processes, as well as adherence to planning and production program. Responsible for the management and coaching of the led. Activities of this function: • Supervision of Production in the area of cosmetics of approximately 140 different formulas. • Management of people promoting the development of employees; • Leadership in investigations of Quality deviations from data collection, interviews, elaboration of Root Cause Problem Solving using Quality tools such as Brainstorming, Ishikawa Diagram and elaboration of Action Plan; • Daily monitoring of shopfloor to ensure organization, 5S and Housekeeping of manufacturing area; • Evaluate and monitor daily safety indicators, such as safety dialogues, observation of behavior at work, monitoring of risk activities, as well as ensuring a good investigation of accidents and / or incidents; • Participation and monitoring of new product launches; • Reduction of cycle time in the Sundown manufacturing process from 8 to 6 hours; • Increase productivity and improve performance through creation and participation in multidisciplinary groups • Responsible for the Purified Water Generation System;
Staff: 1 head of department and 31 pharmaceutical operators Coordinate all matters and actions related to the Dispensation of Raw Materials to evaluate, plan and monitor the daily development of processes and adherence to the Production Program, always respecting corporate policies. Coordinate on-site investments, budgets and projects related to the distribution area. Keep the site indexes (Quality, Productivity, Financial and Security) under control and within the goal. Contribute in audits (external and internal). Responsible also for the management and coaching of the led as well as for the formation and development of the same in the function Implementation of operator to handle materials, increasing productivity in 25% in delivering heavy batches
Staff: 1 Head of Department/35 operators Production Supervision in solids, in charge of assessing, planning and monitoring the daily development of the processes/production and the adherence to the production program. Also in charge of managing and coaching the staff, as well as for developing them in their positions. Main roles comprised in the position: • Production coordination in Manufacturing solid pharmaceutical materials with over 300 different presentations, such as pills, tablets and capsules, producing over 135,000,000 units/year. • People management, encouraging the employees’ development, as well as the succession plan for the current position; • Production KPI coordination and setting of actions to reach target. KPIs: OEE/HNA (Unallocated Hours)/PCT(Planned Cycle Time)/Productivity/Expenses; • Implementation coordination and support to Lean Manufacturing programs: VM,SMED,VSM,TPM, Kaizen and 5S; • Assessment and monitoring of the daily development of processes, as well as the adherence to the production program. Constant challenge to the production volume and its uptake; • BP and LRP preparation and reviewing, involving: occupation of the production lines, HC, investment, expenses, outcome and production standards; • Involvement in launching of new departments and equipment; • Support and monitoring of HSE and Quality programs. Ensure good investigation of accidents and quality issues, as well as the compliance with the action plan; • Production coordination in the manufacturing of solids with about 300 different presentations, such as pills, tablets and capsules, producing over 135,000,000 units/year. • Holding innovation-focused feedback meetings; o Main projects and outcomes 500 KBRL/year win by using the process loss reduction Project in Dorflex® manufacturing Installation of Fette 3090 compressor with rated speed of 700mil cpr/hr
• Representante da área de Desenvolvimento Industrial para processos de Troubleshooting na área de Produção: - análise de melhorias de processo - manutenção de produtos - budget quotation para projetos • Conhecimento dos indicadores de produção (HNA, produtividade, OEE e PCT) • Responsável pela implementação da ferramenta Lean Manufacturing na área de Desenvolvimento Industrial e participação de reuniões de melhoria focada da área produtiva: Gestão Visual, SMED, quadro FIFO e VSM. • Participação nos projetos de 5S e Kaizen • Coordenação de projetos de Qualificação de novos fornecedores de Matérias Primas. • Atuação em auditorias externas em fornecedores e auditorias internas. • Conhecimento dos processos de desenvolvimento de novos produtos. • Suporte técnico à área industrial em manutenções de produtos sólidos, líquidos, semi-sólidos e injetáveis. • Suporte à área industrial em reclamações de mercado. • Elaboração e avaliação de Controles de Mudança e Desvios de qualidade.