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Experienced Quality System Manager with a demonstrated history of working in the hospital & health care industry. Skilled in Medical Devices, Management, Business Process Improvement, Auditing, and Validation. Strong information technology professional with a Master of Business Administration (MBA) focused in Gestão de Marketing from Fundacao Getulio Vargas.
Currently Available For New Opportunities
View- Website:
- clicktreinamentos.com
- Employees:
- 277
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RetiredCurrently Available For New Opportunities Dec 2019 - Present
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Manager - Global Quality System - Product Lifecycle Management (Plm)Johnson & Johnson Apr 2013 - Dec 2019São José Dos Campos Area, BrazilPart of the global PLM, representing and responsible for Document Control in Latin America under Group of Consumer Products. Provide management and support to this process and assist users from the four (4) manufacturing sites and from some marketing companies (15).Foster robust quality and compliance document control process through partnering with: Research and Development, Operations and Quality, areas to achieve a timely support to initiatives, also technical/process resolution where applicable.Accountable to ensure compliance of document control processes in the region and to implement JJ Policies and Standards related to business. Provide guidance for problem solving.Responsible for budgeting account control of local expenses of the team located in Brazil. -
Manager - Regional Quality System - Latin AmericaJohnson & Johnson Jan 2007 - Mar 2013São José Dos Campos Area, BrazilResponsible for Computer System Validation of applications with regional scope in Latin America. Also responsible for the SAP Quality Module and to provide a compliance to support the GxP (Good x Practices) for new regional applications in Latin America and changes as well. Lead the validation effort of the SAP upgrade version (ECC 6.0) in Latin America region.Responsible for management in the region the Authorization for Product Release (APR) which is the process to assure that product has been developed, manufactured and approved is in compliance with quality and local regulatory requirement prior to its launching. Responsible for the APR process improvement in 2007, with the creation of 3 set of documents to support product development, product manufacturing and finally product release for launching to the market, allowing parallel rollout of SKUs.Improve the tool used by end users requests of Document Control application (Global Specification System) by recreating user forms in the SharePoint Site in 2010.Responsible in the Latin America region for global platform of change control, audits and CAPA.Lead Credo Action for team work improvement in Q&C team located in Brazil with significant improvement on communication tools. The same tools were rolled out to the region in same year (2008).
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ManagerJohnson & Johnson 2002 - 2013
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ManagerJohnson & Johnson 2007 - 2008
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Associated Scientist - Regional Quality System - Latin AmericaJohnson & Johnson Jan 2001 - Dec 2006São José Dos Campos Area, BrazilLead the regional deployment of the Global Platform for Document Control (2005).Lead a regional Quality System harmonization and design the cross country audit program to support sites in preparation for independent audits. Lead KQI reporting process.Lead the preparation of plant for certification in the Brazilian Health Authority regulation for Cosmetic, Medical Device and Pharmaceutical products (2002-2003).
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Associated Scientist - Regional Quality System - Latin AmericaJohnson & Johnson Apr 1999 - Dec 2000Cali, ColombiaInternational assignment for almost 2 years to lead Quality, in Cali Plant in Colombia to improve the local quality system according to company standards and local requirements. Redesigned area structure and personnel requirements.Hired and developed the team, providing training and development material.Responsible for labs improvements, rebuilding and equipment acquisitions (autoclave, chromatograph). Lead the implementation of GMPs process improvement at the operations.
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Associated Scientist – Regional Quality System - Latin AmericaJohnson & Johnson Jan 1994 - Mar 1999São José Dos Campos Area, BrazilResponsible for internal audit program in Brazil and for conducting quality system audits to evaluate and report level of compliance to company's procedures and regulatory requirements. Hosted Health Authority Inspections and Corporate audits.Lead the preparation for mandatory certifications of condoms in ISO 9001 (1996). Improve the Quality System with implementation of: Calibration program, Stability of marketed, Retention sampling program, Validation, NC/Deviation and CAPA procedures. Develop GMP training material and provide GMP training for new employees. Responsible for Site Management Review and KQI to Manufacturing site board.
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ResearcherJohnson & Johnson Mar 1987 - Dec 1993São José Dos Campos Area, BrazilProduct development and maintenance in R&D for Oral Care Franchise, focused in the development of toothbrushes. Main launches are toothbrushes with: rounded bristle; transparent handle; flavored handle; with stamping for kids among others.
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Quality AnalystJohnson & Johnson Jan 1980 - Mar 1987São José Dos Campos Area, BrazilDevelopment of Statistic Product Reports of several products at Consumer to monitor quality and to provide assistance for Quality and R&D areas on product metrics and studies: distribution, t-student, sampling plan, operating confidence interval, Operating Characteristic Curve – OCC, AQL, SPC.
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TraineeJohnson & Johnson Dec 1977 - Dec 1979São José Dos Campos Area, BrazilWorked at Chemical Lab and in quality process control of cosmetic and medical device performing product and material tests. Lead the improvement of GMP processes in the Lab.
Araceli Santos Skills
Araceli Santos Education Details
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Gestão De Marketing -
Chemical Engineering
Frequently Asked Questions about Araceli Santos
What company does Araceli Santos work for?
Araceli Santos works for Currently Available For New Opportunities
What is Araceli Santos's role at the current company?
Araceli Santos's current role is Retired.
What is Araceli Santos's email address?
Araceli Santos's email address is ar****@****jnj.com
What is Araceli Santos's direct phone number?
Araceli Santos's direct phone number is (800) 950*****
What schools did Araceli Santos attend?
Araceli Santos attended Fundacao Getulio Vargas, Universidade De São Paulo.
What skills is Araceli Santos known for?
Araceli Santos has skills like Gmp, Quality System, Cross Functional Team Leadership, Quality Management, Process Improvement, Quality Assurance, Validation, Change Control, Capa, Document Management, Management, Change Management.
Who are Araceli Santos's colleagues?
Araceli Santos's colleagues are Jose Varela, Robert Doumet, Luka Raznatovic, Veronica Mallari, Ailson Santos, Kathryn Scott, Marijan Basic.
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Araceli Santos
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