
Timeline
About me
Pharmacist, Quality Professional, Clinical Research Specialist, Senior Auditor , GXP , Quality and Compliance |
Education

Fundação vanzolini
2008 - 2010Specialist quality management post graduationStatistics applied on Quality Systems, Quality Metrics and KPIS, Quality Management tools, 5 S, 6 Sigma, Brazilian and Global Quality Standards, GXP, ISO, audit process and auditor skills.

Invitare
2007 - 2008Specialist clinical trials post graduation
Pós graduação - faculdades oswaldo cruz
1995 - 2000Bachelor's degree pharmacy
Experience

World courier
Aug 2007 - Jun 2016Regional management on QA compliance, for all World Courier depots in Latin America and South Africa. Auditing and assistance on local projects reçlated to quality and compliance, non conformances and CAPA, metrics, receiving and assisting on external audit processes, performed by pharmaceitical industries' representatives, CROs, local and global regulatory authorities. Regional consolidation on ISO 9001 and 14001 policies, and other guidelines related. Training elaboration and performance on topics related to GXP (Good Clinical Practices, Good Manufacturing Practices, Good Distribution Practices). Show less
Quality Assurance Manager - Latin America and Africa
May 2014 - Jun 2016Quality Assurance Deputy Manager - LATAM
Feb 2013 - May 2014Quality Assurance Project Manager
Feb 2011 - Feb 2013Quality Assurance Specialist
Aug 2007 - Feb 2011

Md quality management and consulting
Oct 2016 - Jun 2019General managerDeveloping projects on Quality Management and Compliance for pharmaceutical supply chain companies. - Assistance on preparation for quality certifications (ISO 9001, ISO 14001, GXP and others applicable). - Elaborating and reviewing quality documentation related: Quality Manuals, SOPS, Work Instructions. - Providing trainings related to quality assurance and quality compliance for internal team: "Quality Management", "Preparation for Quality Certifications", "GMP (Good Manufacturing Practices)", "GDP (Good Documentation Practices)", "Clinical Research 101", "Good Clinical Practices". - Performing and leading internal audits in compliance to applicable regulations or ISO 9001 related. - Providors qualification and auditing. - Technical translation and revision for quality related documents ( from Portuguese to English and Spanish versions). - Elaborating internal qualification and validation programs in accordance with applicable regulations. - Elaborating internal training programs for all company employees, according to applicable quality standards.- Invited Auditor, Sindusfarma Quality Award for Pharmaceutical Providors Show less

Instituto racine
Jun 2019 - Jun 2023Teacher - quality management and compliance
Johnson & johnson
Oct 2019 - Oct 2020Quality coordinator
Sqa services, inc.
Dec 2020 - Jun 2023Senior auditor , gxp
Medpoint, llc
Feb 2023 - Jun 2023Auditor sênior
Intrials clinical research
May 2023 - nowQuality Assurance Lead
Jan 2025 - nowQuality Assurance Coordinator - Latin America
May 2023 - Feb 2025
Licenses & Certifications

Iso 9001 - 2015 - lead auditor
International register of certificated auditors
Volunteer Experience
Volunteer on social projects in Brazil
Issued by Art of Living Foundation - United States on Oct 2015
Associated with Mariana Conceição
Languages
- enEnglish
- spSpanish
- poPortuguese
- frFrench
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