Marina  Farias

Marina Farias

QA Validation Specialist @ Hemobrás

About

Quality Assurance Validation Specialist with 3+ years of experience in pharmaceutical and biotechnology industries. Skilled in Commissioning, Qualification, and Validation (CQV) for equipment, facilities, transportation, and computerized systems (CSV). Strong expertise in ALCOA+ data integrity, FDA/EMA compliance, GAMP 5, and Annex 11. Collaborative team player with experience aligning validation activities with project timelines and regulatory requirements.

Country

-

City

United States

Industry

Pharmaceuticals

Skill

Liderança, Tomada de decisão, Comunicação, Resolução de problemas, GMP, CSV, GAMP5, Habilidades analíticas, willingness to travel, Adaptability, Technical Problem-Solvin, Risk Management and Regulatory Compliance , Development and Execution of Validation Protocols (IQ, OQ, PQ), Commissioning, Qualification, and Validation (CQV), Voluntariado, Life Sciences, CQV, Validation, GxP, Quality Assurance

Experience

Hemobrás

QA Validation Specialist

Hemobrás

LinkedIn
2022-2 - 2026-2 · 4 yrs 1 mo

Goiana, Pernambuco, Brazil

Development and execution of commissioning, qualification, and validation protocols for Equipments, Environments, Process Validation, Transport Validation, Holding Time and Mixing Studies, Media Fill, Utilities and Filtration Systems in the pharmaceutical and biotechnology industries. Preparation and maintenance of comprehensive technical documentation, including validation protocols, plans, reports, periodic review reports (PRR), validation master plans (VMP), user requirement specifications (URS), and standard operating procedures (SOPs). Execution and documentation of process, cleaning, transport, holding time, and media fill validations, in accordance with regulatory standards and internal procedures. Identification, assessment, and mitigation of risks associated with CQV activities through the implementation of effective strategies. Troubleshooting and resolution of issues related to equipment and process performance, ensuring operational efficiency and regulatory compliance. Investigation and documentation of quality deviations, change controls, and out-of-specification (OOS) results. Active participation in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Support and monitoring of inspections and audits conducted by national and international regulatory authorities. Collaboration with cross-functional teams to ensure alignment of CQV activities with project timelines and the successful delivery of validated systems. Ensuring regulatory compliance with FDA, EMA, GMP, and GAMP standards, while upholding internal quality and documentation requirements.

Universidade Federal da Paraíba

Doctoral Student

Universidade Federal da Paraíba

LinkedIn
2020-3 - 2026-2 · 6 yrs

João Pessoa, Paraíba, Brasil

PhD scholarship student with an emphasis on the development of pharmaceutical formulations with antimicrobial and anti-inflammatory action

Universidade Federal da Paraíba

M.Sc

Universidade Federal da Paraíba

LinkedIn
2018-3 - 2020-2 · 2 yrs

João Pessoa, Paraíba, Brasil

Development of molecular hybrids derived from Perillyl Alcohol and Borneol with antimicrobial activity.

Mercadão dos Medicamentos

Pharmacist

Mercadão dos Medicamentos

2019-3 - 2025-8 · 6 yrs 6 mos

Santa Rita, Paraíba, Brasil

- Supervised pharmacy operations and pharmaceutical supply management. - Monitored regulatory updates and ensured compliance with recalls and stock controls. - Managed inventory, storage, and distribution of medicines and medical supplies. - Oversaw multidose dispensing and medicine fractionation processes. - Reviewed prescriptions for legal, technical, and dosage accuracy. - Controlled antimicrobial and high-risk medication usage; maintained compliance records. - Assessed non-standard medication requests and recommended alternatives.

Complexo Hospitalar Clementino Fraga

Pharmaciy Supervisor - Hospital

Complexo Hospitalar Clementino Fraga

2020-4 - 2021-9 · 1 yr 6 mos

João Pessoa, Paraíba, Brasil

- Oversaw operations of the Pharmaceutical Supply Center and hospital Dispensing Pharmacy; - Monitored ANVISA updates to identify recalled medications and coordinated stock removal; - Managed receipt, storage, and inventory of medicines and medical supplies, ensuring compliance with Good Storage Practices; - Supervised medicine fractionation and multidose dispensing processes; - Reviewed and validated medical prescriptions for legal, technical, and dosage accuracy; - Controlled and tracked antimicrobial and high-risk medication usage; maintained compliance records in CCIH system; - Evaluated non-standard medication requests and recommended standardized alternatives; - Coordinated procurement and dispensing of state-provided medications for patients with occupational accidents, HIV, Tuberculosis, Leprosy, Syphilis, and Toxoplasmosis.

Drogasil

Pharmacist

Drogasil

LinkedIn
2017-11 - 2018-4 · 6 mos

João Pessoa, Paraíba, Brasil

Education

Universidade Federal da Paraíba

Universidade Federal da Paraíba

LinkedIn

Desenvolvimento e Inovação Tecnológica em Medicamentos

2020 - 2024 · 4 yrs

Desenvolvimento de forma farmacêutica com atividade antimicrobiana e antiinflamátoria. Estudo de estabilidade e testes não clínicos.

ICTQ - Instituto de Pós-Graduação para Farmacêuticos

ICTQ - Instituto de Pós-Graduação para Farmacêuticos

LinkedIn

Assuntos Regulatórios na Industria Farmacêutica

2022-8 - 2024-1 · 1 yr 6 mos
ICTQ - Instituto de Pós-Graduação para Farmacêuticos

ICTQ - Instituto de Pós-Graduação para Farmacêuticos

LinkedIn

Regulação e Qualidade na Industria Farmacêutica

2022-6 - 2023-9 · 1 yr 4 mos
Faculdade Única

Faculdade Única

LinkedIn

GESTÃO DE FARMÁCIA HOSPITALAR

2021-11 - 2023-4 · 1 yr 6 mos
Faculdade Única

Faculdade Única

LinkedIn

FARMÁCIA CLÍNICA E HOSPITALAR

2021-11 - 2023-4 · 1 yr 6 mos
ICTQ - Instituto de Pós-Graduação para Farmacêuticos

ICTQ - Instituto de Pós-Graduação para Farmacêuticos

LinkedIn

Gestão da Qualidade e Auditoria em Processos Industriais

2022-11 - 2023-6 · 8 mos
Faculdade Única

Faculdade Única

LinkedIn

Farmácia Clínica e Prescrição Farmacêutica

2021-4 - 2022-4 · 1 yr 1 mo
Universidade Federal da Paraíba

Universidade Federal da Paraíba

LinkedIn

Farmacoquímica

2018-3 - 2020-2 · 2 yrs

Pós graduação em Produtos Naturais e Sintéticos Bioativos, área: Farmacoquímica. Atuando no desenvolvimento de fármacos com atividade antifúngica.

Universidade Federal de Campina Grande

Universidade Federal de Campina Grande

LinkedIn

Farmácia

2012-2 - 2017-10 · 5 yrs 9 mos

Monitora da disciplina de farmacotécnica II por 2 períodos, desenvolvendo atividades práticas com formulações sólidas e semissolidas. Trabalho de conclusão de curso: Estabilidade preliminar de formas magistrais contendo hidroquinona.

Marina Farias 's Contact Information

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