Experience

SimplerQMS A/S

• Denmark
• Software Development
• 1 - 100 Employee

• Life Science Content Writer

  • Jan 2023 - Present

  SimplerQMS provides a complete electronic quality management system (eQMS) software to help medical device and pharmaceutical companies work efficiently and comply with regulatory requirements. - Produced life science content for articles regarding quality management processes, such as document control, change control, training management, audit management, CAPA, deviations, non-conformances, complaints, risk management, and equipment management. - Comprehensive knowledge of international standards: ISO 13485 (medical devices), ISO 15189 (medical laboratories), ISO 14971 (risk management), and ISO 9001 (quality systems). - Produced written material concerning the European regulation 2017/745 (Medical Device Regulation - MDR), 2017/746 (In Vitro Diagnostic Regulation - IVDR), and 765/2008 (CE marking). - Developed and updated product pages of core QMS modules as a marketing strategy to offer software as a service (SaaS) for Life Science companies. - Knowledge of the regulations: FDA 21 CFR Part 210 (cGMP for drugs), FDA 21 CFR Part 211 (cGMP for finished pharmaceuticals), FDA 21 CFR Part 820 (quality systems), FDA 21 CFR Part 11 (electronic signatures), Medical Device Single Audit Program (MDSAP), and EU GMP Annex 11 (electronic signatures). Show less



L&C

• Brazil
• Information Technology & Services

• Scientific Writer | Technical Writer

  • May 2021 - Present

  A company focused on producing scientific content for life science companies and professionals. Work alongside other science, health professionals, and entrepreneurs in the production of technical, informative, educational, or promotional medical content. - Worked with a high volume of information, maintaining email, data, and reports organized by using an archival of documents uploaded and shared on Google Workspace. - Developed SEO-optimized texts on Microsoft Office: Word, PowerPoint, and Excel, employing translation and back translation to Portuguese and English accurately. - Ensured all data discrepancies from the project scope, budgets, and timelines were tracked and clarified using information defined by the client. - Performed literature reviews of scientific material, searching databases quickly and precisely to support the project deadline. - Worked on several projects in parallel, routinely reviewing the documents for accuracy, timeliness, and completeness. Show less



Instituto Butantan

• Biotechnology Research
• 700 & Above Employee

• Scientific Research Associate

  • Sep 2016 - May 2021

  Butantan Institute is the largest producer of vaccines and serums in Latin America and the main producer of immunobiological in Brazil. Led scientific research that culminated in the international publications of 8 scientific articles and 2 chapters of technical books.- Coordinated 5 scientific research projects in the areas of molecular biology, biotechnology, bacteriology, and diagnostic tests, with 100% approval of the subsidy proposals and ethics committee submitted.- Managed project and laboratory budgets, always looking for new manufacturers, suppliers and internal and external partnerships to acquire inputs and materials.- Coordinated tasks and activities related to the laboratory, ensuring Good Laboratory Practices and compliance with Standard Operating Procedures (SOP), to ensure the feasibility of the work.- Participated in periodic meetings in the different areas related to the projects to develop internal and external partnerships, ensuring the execution of 100% of the work steps within the defined schedule.- Developed laboratory tests and diagnostic assays for diarrhea and urinary tract infection, such as immunochromatographic, PCR, and ELISA tests, contributing technically and scientifically to all stages of project feasibility.- Developed in collaboration with research on Dengue and Zika viruses, during the 2015-2016 epidemic, for the development of a diagnostic assay with monoclonal antibodies, carrying out initial feasibility assessment, initial formulations, and laboratory tests.- Transformed the existing documents and standard operating procedure to an online version employing writing, proofreading, and reviewing skills. Shared documents with the team using Google Workspace and Google Drive.- Hands-on experience in proposal development, project management, SOPs/processes writing, oral presentations, budgeting, and report writing.- Followed guidelines and legislation regarding Good Laboratory Practices and Internal Ethical Committee. Show less

• Life Science Research Technician

  • Apr 2016 - Aug 2016

  Responsible for expressing and purifying synthetic antibodies against bacterial toxins.- Knowledge in SOPs/processes writing, oral presentations, budgeting, and report writing.- Acquired knowledge of complex scientific information by doing a vast literature search and summarizing the data.- Writing scientific content to disseminate the results obtained in article format on Microsoft Office: Word, Excel, and PowerPoint.

• Scientific Researcher

  • Apr 2014 - Apr 2016

  Responsible for developing an immunobiological assay for the diagnosis of neglected diseases.- Hands-on experience in the development of immunochromatographic tests (lateral flow) for detection of uropathogenic Escherichia coli toxins.- Knowledge of bioconjugation strategies to conjugate antibodies to streptavidin and colloidal gold.- Prepared reports and delivered oral presentations to disseminate the results obtained in relevant meetings, showing written and verbal communication skills.- Managed project resources and strict timelines and deadlines demonstrating abilities to be flexible, motivated, and resourceful.- Employed several molecular biology techniques to perform assays with high-quality output, good eye for detail, and problem-solving skills. Show less

• Scientific Researcher Trainee

  • Aug 2013 - Jul 2014

  Responsible for conducting assays to optimize the manufacturing process of immunochromatographic assays (lateral flow).- Experienced with standard operating procedure writing, reports preparation, and oral presentations.- Hands-on experience with literature search in life sciences.- Participated in congress, communicating proactively and effectively my research results.- Worked at biosafety level 2.



RD

• Brazil
• Retail
• 700 & Above Employee

• Pharmacist

  • Nov 2020 - Apr 2021

  RD is a leading company in the Brazilian pharmacy market, with over 2,500 stores in all Brazilian states. Responsible for controlling and dispensing antimicrobial and psychotropic drugs. - Worked with federal regulatory legislation and with local state legislation, preparing technical and scientific reports on drug dispensing procedures (ANVISA RDC 344/98). - Led a team of 3 pharmacists, teaching new software and methods for more efficient execution of daily work, successfully exerting leadership and positive influence with co-workers to create and maintain a healthy environment. - Interacted with local teams in the financial, regulatory and management sectors in order to align drug sales results and project the store's expected revenue in the coming months. - Organized all documents and reports regarding overdue and incorrect regulatory affairs, achieving compliance with federal and local legislation within 2 months. Show less