Experience

ICONACY Orthopedic Implants, LLC
• United States
• Medical Practices
• 1 - 100 Employee
• Gestor da Area de Qualidade

  • Feb 2010 - Present


Prosintese / Bio 2

• Gestor de Qualidade e R&D

  • Feb 2010 - Present

  Group companies : Prosintese distributor Prosintese Industry and Distributor BIO2 . Responsible for certification, development and implementation of Quality Systems (RDC 59 GMP , ISO 9000 , ISO 13485 and CE FDA 510 K) ,Regulatory Affairs , Research & Development (R & D). Audits of quality internal and external suppliers ; Solid experience in Sanitary working in the area of Regulatory Affairs. Coordination of Regulatory Affairs area , analyzing the applications for registration of products for health , risk level I, II , III and IV ,monitoring the status of processes and situations in Brasilia and DOU and DOE Experience in regulatory compliance for installation and deployment of factories, production areas and distribution in the pharmaceutical , medical hospital and health products, at the municipal , state and federal . Adequacy of the company before official bodies ( ANVISA / COVISA / CETESB / AVCB / VISA) ; Representation Company Along the Class Associations and Government Entities . Participation in meetings for regulatory development and publication of new technical standards ; Responsible for performance evaluation and people management area regulatory , quality and engineering ; Preparation and training of operational procedures related to the areas of production ,management, quality assurance and quality control . Responsible for developing and representing the company in the protection of industrial property rights, being a professional who combines technical expertise and / or legal area of Trademarks , Patents and other matters related to Industrial Property.



SIN - Sistema de Implante Nacional

• Brazil
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Mar 2005 - Jun 2008

  Responsible for the validation of productive processes, equipment and utilities assuring a larger efficiency in the processes, as well as safety. Challenge of processes looking for the improvement in the production of dental implants, plates and screws for facial maxilo surgeries and other prosthesis components. Responsible for the biomaterials division, implementation of new products for the health area, such as bio membranes of collagen, inorganic mineral, ionic implantation in surface of materials.



Eurofarma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation of Coordinator

  • May 2000 - Aug 2004

  Partcipation and Construction management of a liquid sterile area allowing an increased installed capacity of 150 % and 5 % in the initial total Sales volume. Validation of all of the utilities of the factory as: water for injection, purified water, HVAC, compressed air system, sterilization tunnels, vacuous system, thermal validations with the aid the portable Kaye equipment. Partcipation and Construction management of a liquid sterile area allowing an increased installed capacity of 150 % and 5 % in the initial total Sales volume. Validation of all of the utilities of the factory as: water for injection, purified water, HVAC, compressed air system, sterilization tunnels, vacuous system, thermal validations with the aid the portable Kaye equipment.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technology and Validation Senior Analyst

  • Jan 1996 - May 2000

  Responsible for the validation of compression processes, production and cleaning to obtain a better efficiency and safety in the productive area. Responsible for the technical complaints and returned products. Responsible for the validation of compression processes, production and cleaning to obtain a better efficiency and safety in the productive area. Responsible for the technical complaints and returned products.


Boehringer Ingelheim
• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Analista de Laboratório Sr.

  • 1994 - 1995

Baxter Healthcare
• Australia
• 1 - 100 Employee
• Analista de Laboratório Pleno

  • 1990 - 1994