Aline Godoy

Quality Assurance Specialist - 3M Health Care @ 3M

About

Pharmacist-Biochemist from USP with 6 years of experience with Quality Assurance. Knowledge in pharmaceutical technology development, formulation and in vitro release techniques. Experience in medium and large companies in the pharmaceutical and chemical sector, having extensive experience with the SAP system, data integrity, KPI, quality tools, development of new sources of raw material with formulation tests, supplier qualification, project management and development, good manufacturing practices and application of training.

Country

Brazil

City

Campinas

Industry

Pharmaceuticals

Skill

Habilidades de apresentação, Apresentações técnicas, Técnicas de laboratório, Inglês, Microsoft Office, SAP, TrackWise, Garantia de qualidade, Farmacotécnica, Formulação, Controle de mudanças, Boas práticas de fabricação (BPF), Qualificação, Avaliação de fornecedores, In vitro, Especificações, Procedimento operacional padrão (POP), Capacidade analítica, Resolução de problemas, Teste de bancada

Experience

Quality Assurance Specialist - 3M Health Care

2024-11 - Present · 1 yr 10 mos

Sumaré, São Paulo, Brasil

- Responsible for evaluating and managing change control; - Responsible for preparing and reviewing protocols and reports for Process Validation, Cleaning Validation, and Equipment Qualification;

Quality Analyst Pl.

Ourofino Saúde Animal

2023-4 - 2024-11 · 1 yr 8 mos

クラビニョス, SP

- Formulation tests on the bench to develop new sources of raw materials; - Qualification, development and management of suppliers of APIs, excipients, packaging, national and international service providers; - Investigation of quality deviations, interfacing with suppliers and formulation; - Assessment and approval of technical specifications of new suppliers; - Opening and management of change control for the implementation of new sources of supply;

Quality Assurance Analyst Jr

Croda

2021-7 - 2023-3 · 1 yr 9 mos

Campinas, São Paulo, Brasil

- Coordination, research and analysis of regulatory assessment reports and qualification of raw materials (origin, composition, licenses and biodiversity); - Responsible for monitoring and reporting issues related to the quality of warehouses (temperature and humidity), as well as the review and preparation of SOPs for the system; - Responsible for the end-to-end process of entries in the MM and QM modules of the SAP system, data management, automation and support in the quality area; - Responsible for implementing and maintaining standards (ISO 9001, EFfCI, GMP and RSPO); - Responsible for the development and management of internal indicators (KPIs); - Responsible for carrying out and monitoring the entire process from service, negotiation, registration, reporting, support, qualification, evaluation and selection of suppliers (raw materials, packaging, carriers, warehouses, tollers and third parties); - Management of pest control processes, from schedule planning, supplier receipt and contract management; - Support and monitoring of CAPAs and intercompany complaints;

Quality Assurance Analyst Jr

Boehringer Ingelheim

2020-12 - 2021-6 · 7 mos

Paulínia, São Paulo

- Assistance and support in the management of new product manufacturing projects, with monitoring and checking of batch records; - SAP system management for analysis and results; - Bibliographic research in the Brazilian and European Pharmacopoeia, for the development of manufacturing processes;

Quality Assurance Intern

Boehringer Ingelheim

2020-2 - 2020-12 · 11 mos

Paulínia, São Paulo

- Responsible for supporting the investigation of deviations and change control with the monitoring of customer service and complaints; - Support, follow-up and research to guarantee good manufacturing practices in third parties and elaboration of Quality Agreements; - SAP system management for analysis and results; - Monitor and support the qualification of new raw material and packaging suppliers in Trackwise;