Alexandre Lima
Specialist in Regulatory Affairs and Quality – Sanitary Responsible at Ivoclar LATAM- Claim this Profile
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Português Native or bilingual proficiency
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English Full professional proficiency
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Francês Elementary proficiency
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Espanhol Limited working proficiency
Topline Score
Bio
Credentials
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Auditor Interno em ISO 13485:2016 e MDSAP
TÜV SÜDApr, 2023- Nov, 2024 -
Certificados de Calibração - Critério e Interpretação
Interaction PlexusAug, 2022- Nov, 2024 -
Formação de auditores internos (RDC 665/2022 e ABNT NBR ISO 13485:2016 - Baseado nos modelos do MDSAP – Medical Device Single Audit Program)
ABIMOJun, 2022- Nov, 2024 -
Formação de Auditores Internos - RDC 16/2013 e ABNT NBR ISO 13485:2016 - Baseado nos modelos do MDSAP – Medical Device Single Audit Program
ABIMOJun, 2021- Nov, 2024 -
Evento RD Station
Resultados DigitaisDec, 2020- Nov, 2024 -
Certificado de Conclusão de Nível A1 de Francês
McGraw HillJun, 2020- Nov, 2024 -
Inbound Exponencial e Lançamentos
Copy Academy®Jun, 2020- Nov, 2024 -
Certificação em Regularização de Medicamentos Similares, Inovadores e Genéricos
Revisa Cursos - Assuntos Regulatórios
Experience
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Ivoclar LATAM
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Medical Equipment Manufacturing
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1 - 100 Employee
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Specialist in Regulatory Affairs and Quality – Sanitary Responsible
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Mar 2022 - Present
• Substitute sanitary responsible;• Provide regulatory strategy for the registration and launch of new products, as well as for changes in registration and notifications of medical devices with ANVISA;• Conduct the Certification of Conformity (INMETRO) of the products under his responsibility, performing the interface between the OCP's and the company's factories in the world.• Carry out notifications and monitoring of field actions with ANVISA;• Maintenance of up-to-date area and global control systems;• Elaboration and maintenance of Procedures and Work Instructions under my responsibility;• Strong commitment to local and global procedures;• Guiding the other areas of the business in relation to the regulatory requirements of the Health Products sector;• Collaboration with the main interface areas, such as Import, Marketing, Commercial, among others;• Actively participate in working groups at Associations and meetings with regulators, when designated;• Support the regulatory team in Latin America for regulatory and quality activities;• Work on renewing and updating the Sanitary Licenses of the company's Branches together with Sanitary Surveillance, Class Councils and ANVISA;• Accompanying internal audits and regulatory and certification inspections;• Participate in the risk management team;• Receive, check, analyze, follow up and organize the cases of feedback, customer complaints and non-conformities sent to the department in the system, in addition to feeding data to create the related critical analysis indicator. Show less
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Regulatory Affairs and Quality Assurance Analyst
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Mar 2021 - Mar 2022
• Analyze and maintain quality documents and records with the competent public bodies and based on current legislation and corporate guidelines.• Implement activities to maintain the company's quality.• Monitor internal audits and regulatory and certification inspections.• Participate in the risk management team.• Analyze and prepare dossiers for new registrations, renewals, post-registration changes and compliance with requirements.• Receive, check, analyze, monitor and organize in the system the cases of feedback, customer complaints and non-conformities sent to the department, in addition to update data for the preparation of the related critical analysis indicator. Show less
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Consulfarma
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Brazil
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Alternative Medicine
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1 - 100 Employee
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Technical coordinator
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Nov 2014 - Mar 2021
• Responsible for the company's quality management system. Review current procedures and develop new ones. Assist in obtaining regulatory documents. Conduct internal audits. Knowledge in investigating quality deviations through reports of non-conformities and quality deviations. • Conduct bibliographic research (journals, Congress Annals, Pharmacopoeias, Scientific Databases, etc.) for the scientific basis of dissemination materials for internal and external products. • Acting in the after-sales relationship with customers, in order to keep them. Table/Organize contracts and technical problem situations reported by consumers of cosmetic products in order to improve the service offered by the company. • Structuring campaigns for products to be launched and already included or not in the portfolio. Produce technical content for product advertising pieces in accordance with current legislation. Coordinate the production of multiple promotion tools, such as online and offline actions and digital channel strategies. • Develop and monitor strategies for events for health professionals. Technical curation of the content of lectures and themes. Coordinate a team of suppliers, speakers, staff and exhibitors in loco, with the objective of organizing all processes that involve the organization of an event: actions for pre, realization and post-event. Show less
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EMS
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Assistant
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Sep 2014 - Nov 2014
• Responsible for quality assurance, responding to non-conformities, quality indicators and system improvements. Responsible for supporting the Technical Manager in the maintenance and improvement of the Quality System, Good Manufacturing Practices Manual, as well as supporting the regulatory affairs sector. Acting with monitoring of quality management processes, monitoring processes of entry and shipment of products, ensuring quality and complying with sanitary legislation, with good quality practices. Show less
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ADA TINA
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Brazil
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Personal Care Product Manufacturing
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1 - 100 Employee
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Regulatory Affairs and Cosmetovigilance Analyst
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Sep 2012 - Sep 2014
• Conduct reconciliation of reports with SAC, Quality and Service Providers. Planning for the preparation and submission of Periodic Cosmetic Surveillance Reports with ANVISA. Support to internal teams regarding the need to include cosmetovigilance in internal projects, especially with the marketing team. Acting in the Scientific Information Service, responding to requests for scientific materials from the sales force and healthcare professionals, providing technical support if necessary. To be the communication point between SAC and Quality in product claim processes. Prepare monthly reports related to Pharmacovigilance and Scientific Information Service. Show less
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Education
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2023 - 2023
Duke University School of Medicine
Regulatory Affairs Training Program, Regulatory Affairs -
2020 - 2021
IPOG - Instituto de Pós-Graduação e Graduação
Regulatory Affairs, Pharmacy -
2012 - 2015
Universidade Paulista
Pharmaceutical Science, General -
2016 - 2017
Centro Universitário Ingá - Instituto de Cosmetologia e Nutrição
R&D - Cosmetic Products, Cosmetology and Beauty -
2011 - 2012
ETEC - Escola Técnica Estadual de São Paulo
Técnico em Informática, Tecnologia da Informação -
2020 - 2020
Faculdade Metropolitana
Marketing, Social Media
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