Elder Santos Email & Phone Number

São Paulo, Brasil

Key Responsibilities:1.Platform Leadership & Oversight:Liquids & Pesticides LATAM: Manage quality operations for seven Contract Manufacturers (CMs) in Brazil, Mexico, and Colombia.Packaging Americas: Oversee quality assurance for four CMs in North America and one in South America.2. Regulatory Compliance & Risk Management:Ensure manufacturing compliance with Good Manufacturing Practices (GMP) and regulatory standards.Maintain and execute periodic risk assessments and Quality Agreements with CMs.3. Operational:Support production operations, including validation processes, tech transfers, and product launches.4. Team Leadership & Development:Lead and mentor a quality team, providing training and support in best quality practices.Manage human resource allocation and support team development plans.

São Paulo, Brasil

Liquids & Pesticides LATAM: Manage and support quality operations for seven CMs in Brazil, Mexico, and Colombia.

Responsabilities:- Equipment, Facilities, and Utilities Qualification: Oversaw qualification and transport validation at the Pouso Alegre and Guarulhos units.- Computerized Systems Validation (CSV): Led CSV activities across all Brazilian operations, covering eight manufacturing sites.- Team Leadership: Managed a team of 24 analysts and 3 supervisors.Product Expertise:- Human and veterinary health products, including: - Small and large volume parenterals - Sterile powder - Freeze-dried products - Hormonal solids and injectables - Solution and suspension eye drops - Antibiotics - Semi-solid and solid dosage forms - CosmeticsRegulatory Compliance:- Ensured processes complied with national and international regulatory requirements, contributing to certifications for: - Guarulhos site: Anvisa, FDA, FDA-Philippines, SFDA, TGA, JMAFF, EMA, EAEU - Pouso Alegre site: Anvisa- Supported product exports to Latin America, Africa, Asia, USA, and Europe.Key Activities:- Ensured departmental activities adhered to the Validation Master Plan (VMP) and related procedures.- Monitored qualification and CSV activities through key performance indicators (KPIs).- Assessed qualification/CSV processes against regulatory requirements (Anvisa, FDA, EMA, EAEU) and quality guidelines (ISPE, PDA, WHO).- Implemented data integrity and quality risk management actions in GMP processes.- Provided technical support for Quality improvement projects.- Facilitated technology transfer projects for manufacturing and packaging interface with qualification activities.- Supported Validation, R&D, Deviation management, Complaints, and Technical/Manufacturing processes.- Contributed to internal and regulatory audits, and client audits.- Acted as Subject Matter Expert (SME) on Container Closure Integrity Testing (CCIT) projects.

Responsible for Equipment, Facilities and Utilities Qualification, Transport Validation and Computerized Systems Validation at the Pouso Alegre / MG and Guarulhos / SP units.During this period I worked with with human and veterinary health products, specifically small and large volume parenterals, sterile powder, freeze-dried, hormonal solids and injectables, solution and suspension eye drops, antibiotics, semi-solid and solid dosage forms and cosmetics.Among the main activities of the period, the following stand out:- Ensure that the department's activities are implemented and executed in accordance with the Validation Master Plan and related procedures.- Monitor the execution of qualification and computerized system validation activities (KPI´s). - Assess the suitability of qualification/CSV processes and strategies against national and international regulatory requirements, such as Anvisa, FDA, EMA, EAEU, and quality guides such as ISPE, PDA, WHO.- Implement actions related to data integrity and quality risk management in GMP processes.

Responsible for managing and executing pharmaceutical manufacturing equipment qualification of Pouso Alegre site where the core capabilities are:- Injectables: powder, liquid and freeze-dried- Sterile eye drops: solution and suspension- Hormones: solid and injectable- Antibiotics- CosmeticsResponsible for managing and executing computerized system validation activities of Pouso Alegre – MG, Brasilia -DF and Embu-Guaçu-SP sites.

Management and execution of pharmaceutical manufacturing equipment qualification of Pouso Alegre site where the core capabilities are:- Injectables: powders, liquid and lyophilized- Sterile eye drops: solutions and suspensions- Hormones: solids and injectables- Antibiotics- CosmeticsManagement and execution of Computerized System Validation activities of Pouso Alegre – MG, Brasilia -DF and Embu-Guaçu-SP sites.Among the activities carried out in the period, the following stand out:- Automatic Visual Inspection: definition of qualification rationale based on Knapp methodology, parametrization and qualification of 4 EISAI/BOSCH machines for particles and cosmetic defects.- Integrity test of containers closed by fusion using High Voltage Leak Detection (HVLD) technology: definition of qualification rationale, parametrization and qualification of 4 Nikka Densok/Bosch KLD machines.- Validation of laboratory equipament / systems such as Empower 3 Enterprise/Personal, OpenLab CDS ChemStation/EZChrom, Spectrum ES, Pharmaspec, among others.- Implementation and Validation of the SoftExpert Excellence Suite system at Anovis unit (Taboão da Serra-SP) responsible for managing the following quality process: Deviations, Change Control, Out of Specification Results (OOS), Market Complaints, and Quality Events.- Implementation and Validation of UltraCRM and CoreFlex systems responsible for the Customer relationship management process- Direct support for regulatory audit inspection readiness activities for Brasília and Embu-Guaçu sites.

Management and execution of pharmaceutical manufacturing equipment Qualification of Pouso Alegre site where the core capabilities are:- Injectables: powders, liquid and lyophilized- Sterile eye drops: solutions and suspensions- Hormones: solids and injectables- Antibiotics- Cosmetics Among the activities carried out in the period, the following stand out:- FAT Eisai Automated Inspection Machine – Eisai/Bosch, Germany- FAT Vial and Ampoule Filling Machine – Bosch/Germany- Thermal Validations using Kaye Validator- Clean room certification activities (sterile and non-sterile areas)- Water System Validation (PW, WFI, PS)- Validation Master Plan Review- Change control evaluation- SOP elaboration- Equipment and Computerized System URS elaboration and review- Equipment and Computerized Systems Risk Assessment – FMEA- Front room in regulatory inspections (VISA/Third parties)- Capability analysis on Minitab to assess equipment qualification data

Campinas E Região, Brasil

- IQ / OQ / PQ of manufacturing, packaging and laboratory equipment.- Computerized system validation: automation and laboratory systems.- Spreadsheet validation.- Risk analysis – FMEA.

Campinas E Região, Brasil

- IQ / OQ of manufacturing, packaging and laboratory equipment.- Periodic review and requalification of equipment.

Maringá E Região, Brasil

Maringá E Região, Brasil

Um dos métodos de produção de CDs é através de células bacterianas imobilizadas, estes processos oferecem inúmeras vantagens frente aos processos produtivos que utilizam de células livres, entre elas, a habilidade em separar a massa celular do líquido de produção, com possibilidade de reutilização, facilitando as operações descontínuas e contínuas, e assim, aumentando a produtividade do reator, bem como a eliminação da necessidade de purificação de enzimas. Considerando a atual necessidade de disponibilização de CDs para a aplicação industrial, tentativas no barateamento de produção e aumento na viabilidade são válidas, desta forma, este projeto tem por objetivo o estudo da estabilidade operacional e de armazenamento de células de Bacillus sphaericus cepa 41 imobilizados, que possam ser utilizadas em vários ciclos de produção e retenham sua viabilidade durante o armazenamento, para obtenção de CDs.

Master Of Business Administration (Mba), Gestão Empresarial

Bacharel, Ciências Farmacêuticas

Activities and Societies: Empresa Júnior Teófilos - Assessoria e Consultoria Farmacêutica, Laboratório de Biotecnologia e Enzimologia

Engenharia De Bioprocessos E Biotecnologia