Experience

Grupoficial

• Brazil
• Wellness and Fitness Services
• 1 - 100 Employee

• Gerente Tecnica

  • Nov 2021 - Present



Consultoria Autônoma

• Independent Consultant

  • Nov 2017 - Present

  Responsible for consulting companies in: Regulatory Affairs (support to regulatory framework, support the evaluation of dossiers for submission to the regulatory body); Quality (preparation of Good Practices Manual, preparation of General Quality Document and Quality Management System, General Training); Production (evaluation of equipment and production routes, equipment sizing, definition of production routes, suggestion of equipment suppliers, process improvements, training); Pharmacotechnical development for new products and improvement of formulations and processes (Troubleshooting) for different pharmaceutical forms (oral solids, softgels, liquids, creams, ointments, injectables, etc.) in different categories (Generics, Similars, Herbal Medicines, Nutraceuticals, Food Supplements , Teas, Cosmetics, Injectables ​​etc...). Show less



Ipanema Saúde Animal & Ambiental

• Brazil
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Quality Assurance Manager | Quality Assurance Coordinator

  • Apr 2019 - Aug 2020

  Reporting to the Technical Director, managing a team of 18 people | Manager responsible for the QMS | Management of Non-Conformities, Customer and Market Complaints | Pest Control Program Management | CAPA’S Management System Management | Management of the Change Controls system. Internal Audit Program Management | Management of the Master Validation Plan | Management of the Supplier Qualification Program | Management of the company-wide documentation system | Integration program management, GMP and training | Final approval of all batches manufactured by the company. Receipt of Regulatory and Customer Audits, maintaining approved and non-critical status, low risk | Management of quality performance indicators (KPI) with monthly monitoring | GAP assessment in regulations | Active participation in the execution of projects, to enable the manufacture of new products and attract new customers | Development and training of people through the “Conversas com Qualidade” program. Continuous follow-up with customers to meet strategies and quality demands | Implementation of the Gemba Walking system with daily Quality Assurance rounds in all areas of the factory | Management and monitoring of quality performance indicators with customers | Participation in the company's billing together with other areas to meet the deadlines set by customers. Show less



TheraSkin Industria Farmacêutica

• Brazil
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Desenvolvimento de Produtos Sr.

  • Oct 2015 - Oct 2017

  New Product Launch Project Management | Responsible for the research and development of the formulations of Klassis TX (Bleaching Cream based on Tranexamic Acid) and Euryale C (Antiage Serum with Vitamin C) products. Definition of productive formulation based on tests carried out on a pilot scale (laboratory), definition of materials for primary packaging, evaluation of the industrial technology available for the definition of the process | Prospecting for materials together with the Supplies area. Economic feasibility and pay-back assessment of new product launch projects | Monitoring the production of pilot batches on an industrial scale ( scale-up) and its respective stability study | Assembling a Dossier of the complete history of the project and review of the technical documentation. Bibliographic research on projects in the galenic development area, search for patents, scientific articles, various literatures and other databases for research (multivitamins, herbal medicines, foods, monodrugs and associations) | Pre-formulation and compatibility studies evaluating the presence of polymorphism in different assets. Monitoring of pilot and industrial batches for process definition (scale-up) and critical process parameters for Validation | Evaluation of investigations of process deviations, change controls, operational procedures, reports and technical opinions. Support to other industry analysts and assistants | Support to the sector supervisor in the preparation of materials for presentations at board meetings | Support to the marketing area for the preparation of descriptive technical material regarding the products being launched or in the portfolio. Technology transfer between equipment of different or the same design and different or the same operating principle, scale-up | Support the regulatory area in the preparation of submission documents to Anvisa via petition or HMP. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Desenvolvimento de Produtos Sr

  • May 2012 - Jul 2015

  Responsible for the development of products (food) in the form of chewable gelatinous gums, developing the technology for manufacturing, and all the research in search of the necessary materials for the product to become viable. Definition of formulation/production process based on tests carried out on a pilot scale (laboratory), as well as the primary packaging materials; Quotation of materials together with the Supplies area aiming at quality with associated cost; Economic feasibility and pay-back assessment of new product launch projects; Monitoring the production of pilot batches on an industrial scale (scale-up) and its respective stability study; Assembling a Dossier referring to the complete history of the project and review of the technical documentation to be sent to the client. Conducting bibliographic research referring to all projects carried out by the galenic development area, including the search for patents, scientific articles, various literatures and other databases for research (multivitamins, herbal medicines, foods, monodrugs and associations); Carrying out pre-formulation and compatibility studies with evaluation of the presence of polymorphism in different assets; Monitoring of pilot batches and industrial batches for process definition (scale-up) and critical process parameters for Validation; Elaboration and evaluation of investigations of process deviations, change controls, operational procedures, reports and technical opinions; Support to other industry analysts and assistants; Support to the sector supervisor in the preparation of materials for presentations at board meetings. Show less



Multilab Farma

• Brazil
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Coordenador de Troubleshooting

  • Jun 2011 - Feb 2012

  Reporting directly to the Research and Development Manager, being responsible for coordinating the Troubleshooting team (about 12 employees) with direct assistance to the company's production area (solids, liquids, semi-solids, herbal medicines and antibiotics) | Responsible for the Technology Transfer of the Oral Solids Handling area for High Shear Mixer and Fluidized Bed. Responsible for Technology Transfer from the Oral Solids Compression area to High Rotation Compressors | Responsible for Technology Transfer with Scale-Up of the Multigrip Handling process between Fluidized Beds | Responsible for Technology Transfer from coating tablets to High Coater. Active participation in daily production plan meetings, aimed at achieving pre-established goals | Evaluation of products that present deviations in the process with immediate action in the reformulation or improvement of the process, based on current regulations (RDC 48), so as not to interrupt production, keeping the product available for sale. Evaluation of products aiming at registration renewal, focusing on pharmaceutical equivalence, bioequivalence and stability study | Product evaluation aimed at process optimization, focusing on reducing production process time, in order to reduce inherent costs. Investigation of process deviations in order to identify the root cause of the deviation, proposing corrective and preventive actions so that the deviation no longer occurs, preparing well-founded and conclusive reports. Technology transfer between equipment of different or the same design and different or the same operating principle, as well as scale-up. Participation in the development program for new active and excipient manufacturers, aiming at cost reduction. Show less



Prati-Donaduzzi

• Brazil
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Gerente de projetos

  • Sep 2009 - Nov 2010

  Reporting to the Research and Development Director, being responsible for managing new product launch projects and technology transfer of line products | Responsible for the Technology Transfer of the Oral Solids Handling area for High Shear Mixer and Fluidized Bed. Responsible for Technology Transfer from the Oral Solids Compression area to High Rotation Compressors | Responsible for Technology Transfer from Tablet Coating to High Coater | Definition of formulation/production process based on tests carried out on a pilot scale (laboratory), as well as primary packaging materials. Conducting bibliographic research referring to all projects carried out by the galenic development area, including the search for patents, scientific articles, various literatures and other databases for research (multivitamins, herbal medicines, foods, monodrugs and associations). Carrying out preformulation and compatibility studies with evaluation of the presence of polymorphism in different assets | Conducting prospection / quotation of materials together with the Supply area aiming at quality with associated cost. Economic Feasibility and Pay-Back Assessment of New Product Launch Projects | Monitoring the production of pilot batches on an industrial scale (scale-up) and its respective stability study. Book assembly referring to the complete history of the project and review of technical documentation for submission for registration at Anvisa, monitoring the project budget. Show less



Cifarma Científica Farmacêutica LTDA.

• Brazil
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Gerente de pesquisa e desenvolvimento

  • Mar 2009 - Aug 2009

  Reporting directly to the Executive Director and Administrative Director, managing a team of around 40 employees. Team management responsible for the development of new products according to the demand and needs of the commercial area. Responsible for the areas of: Pharmacotechnical Development, Analytical Development, Technical Support, Technology Transfer and Improvement, Packaging Development and Stability, with a focus on Bioequivalence (development of solid, liquid, semi-solid, injectable, eye drops, hormones pharmaceutical forms); Evaluation/Adequacy of products for registration renewal (Generics/Similar/Food and Herbal Medicines). Show less



Hypera

• Brazil
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Coordenador de Pesquisa e Desenvolvimento

  • Mar 2007 - Sep 2008

  Reporting directly to the Research and Development Manager, being responsible for coordinating the Technical Support and Technology Transfer team (about 15 employees) with direct assistance to the company's production area (solids, liquids, semi-solids, injectables , eye drops, hormones and antibiotics). Technology transfer between equipment of different or the same design and different or the same operating principle, as well as scale-up. Participation in the development program for new active and excipient manufacturers, aiming at cost reduction. Evaluation of products that present deviations in the process with immediate action in the reformulation or improvement of the process, based on current regulations, so as not to interrupt production, keeping the product available for sale. Evaluation of products for registration renewal, focusing on pharmaceutical equivalence, bioequivalence and stability study. Product evaluation aimed at process optimization, focusing on reducing production process time, in order to reduce inherent costs. Investigation of process deviations in order to identify the root cause of the deviation, proposing corrective and preventive actions so that the deviation no longer occurs, preparing well-founded and conclusive reports. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analista de Tecnologia Farmaceutica

  • Oct 2003 - Mar 2007

  Reporting directly to Technical Services Manager | Work started in parallel with the creation of the sector, being responsible for the development of all documentation used by the sector | Technology transfer between product sites: Trofodermin Cream, Gino-Pletil Cream, Fibrase ointment, Gino-Fibrase, Benalet, Viagra 100mg, Frontal, Aldazide, Pletil, Zoloft. Investigation of process deviations in order to identify the root cause of the deviation, proposing corrective and preventive actions so that the deviation no longer occurs, preparing well-founded and conclusive reports. Process mapping to identify critical points (bottlenecks) | Participation of the Continuous Improvement team, developing projects in different areas, aiming at process optimization. Technology Transfer of Pharmaceutical Products between sites, with adaptation to the production technology as well as the production process, in accordance with national and international regulatory requirements. Technology transfer between equipment of different or the same design and different or the same operating principle, as well as scale-up. Participation in the development program for new active and excipient manufacturers, aiming at cost reduction. Show less



Laboratório Teuto

• Brazil
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analista Farmacêutico

  • 2000 - 2003

  Reporting to Product Development Supervisor | Definition of formulation/production process based on tests carried out on a pilot scale (laboratory), as well as primary packaging materials. Conducting bibliographic research referring to all projects carried out by the galenic development area, including the search for patents, scientific articles, various literatures and other databases for research (multivitamins, herbal medicines, foods, monodrugs and associations). Carrying out preformulation and compatibility studies with evaluation of the presence of polymorphism in different assets | Conducting prospection / quotation of materials together with the Supply area aiming at quality with associated cost. Economic feasibility and pay-back assessment of new product launch projects; Monitoring the production of pilot batches on an industrial scale (scale-up) and its respective stability study. Book assembly referring to the complete history of the project and review of technical documentation for submission for registration at Anvisa, monitoring the project budget. Show less