Celso Castro Email & Phone Number

São José Dos Campos, Sp, Br

Ethicon Brazil (A Johnson&Johnson Company)

The main objective is to maintain high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements. In addition this position is responsible for the absence of significant quality issues and regulatory compliance actions by government agencies, including but not limited to FDA, ANVISA, TGA, Health Canada and Europe.Recent AccomplishmentsSuccessfuly prepared the organization and managed 17 Health Autorities inspections since in the position. Among these inspections, it is important to highlight the first FDA inspection in a Johnson & Johnson Company in the Latin America and the first Unannounced Notified body inspection at Ethicon Brazil.Improved the internal audit process, increasing the knowledge and competency of internal auditors, resulting in deeper internal audits, which significantly contributed to outstanding results in Health Authority inspections.Improved the findings resolution achieving more broader and timely actions, which contributed to reach all the organization metrics.

São José Dos Campos Area, Brazil

Recent AccomplishmentsQA Project Leader for Asset Reconfiguration projects that transferred products from Germany and France Ethicon sites increasing Ethicon Brazil volumes by 20%. QA Project Leader for the Principal Asset Manufacturer project phase 1 which allow Brasil Ethicon site to eliminate importation taxes related to raw materials and components used on Products exported to USA and Europe.Project Leader for the Integration of local Supplier Quality Management (SQM) to the Ethicon WW organization.Project Site leader for the deployment of Adaptiv (QA Management Software) along Ethicon European and North America sites. Recognized with a “Leadership Award” due to the exceptional business results and outstanding behavior related to the Global Leadership Profile.Project leader for Lean Integration project phase 2 which is extending the Lean Integration project to additional suppliers.Several initiatives to increase general employee satisfaction in the areas under my responsibility. Credo Survey performed and results achieved showed increase in satisfaction and no critical area to improve.Main ResultsRaw Material defect rate less than 0.4%First Pass Approval for products from External Manufacturers equal to 100% in the last 12 months.100% completion on external audits related to Brazilian suppliers and external manufacturers.Four audits for ISO13485 certification without any finding on external manufacturers or Supplier Management.No compliance/design issues related to the transfer of products from European sites to Brazil site.Lean Integration project noted as “Integration Level” in previous assessment. Next assessment planed to September 2012.