Isabella Borja Email & Phone Number

• Criação e conferência de planos de inspeção no SAP/eLims• Aprovação de especificação de produto acabado, matéria-prima e embalagem.• Atualização de master data

• Assignment at Analytical Science & Technology Hub LatAm, responsible for managing analyticalmethod transfer and validation between company and external sites in Latin America.• Creation and review of protocols and reports for analytical method transfer and validation.• Statistical and comparative evaluation of results, analytical documentation and raw data review forcompliance to GDocP and data integrity requirements.• Evaluation of method validation strategies and survey of materials and resources needed to projects.• Provision of regulatory and analytical support, including training sessions for external sites.

• Physico-chemical and instrumental analysis of finished and semi-finished drug products for analyticalmethod transfer, stability studies, packaging validation and release analysis.• Investigation of OOS/OOT/OOE results and quality deviations at Trackwise and Salesforce systems.• Managing of laboratory test results in ERP SAP system.• Empower 3 (Waters) deployment team member, acting as Key User and providing support to thelaboratory team.• LabOpex, LeanLab and Housekeeping team member.• Review of Standard Operating Procedures

• Responsible for stability studies for post approval changes of drug products.• Physico-chemical and instrumental analysis for follow-up, long-term, accelerated and photostabilitystudies in industrial and pilot batches.• Analytical support to Quality Control department, performing release analysis of drug products.• Training of new employees.

• Research and evaluation of clinical trials, systematic reviews, and meta-analysis present in databasessuch as PubMed, Medline and Science Direct.• Writing of reports based on the evidence above to demonstrate safety and effectiveness of traditionalmedicines marketed in Brazil.• Evaluation of regulatory status of over the counter (OTC) drug products.• Communication with Brazilian Health Authority (ANVISA) to clarify questions regarding regulatoryaffairs.• Review of technical documentation and leaflet information.

Curitiba, Paraná, Brazil

• Development and optimization of analytical methodologies to quantify drugs in nanostructures(liposomes and nano capsules).• In-vitro (membrane) and ex-vivo (animal skin) study of nanostructures permeation, using Franzdiffusion cell.• Research results presented as undergraduate thesis required for Bachelor of Pharmacy degree.

Specialization, Analytical Development Applied To Pharmaceutical Industry

Bachelor Of Science, Pharmacy

Academic Exchange, Chemisty