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.
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United States
Pharmaceuticals
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

QA Validation Specialist
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.

Pharmacist
Mercadão dos Medicamentos
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.

Pharmaciy Supervisor - Hospital
Complexo Hospitalar Clementino Fraga
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.
Education

Farmácia
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.
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