Quality assurance

Consultant | Life Sciences, specialized on Quality Assurance & Regulatory Compliance with professional experience in projects for the Pharmaceutical Industry and Medical Devices Industry.

CSV Consultant for ARALAB – System Validation (Portugal - April 2020 to Present)
Performance Qualification of ERP solution. Execution, review and reporting of tests on Fitolog.
CSV Consultant for Labatec Farmaceutica – System Validation (Portugal - April 2020 to May 2020)
Performance Qualification of ERP solution. Execution, review and reporting of tests on SAGE X3.

Medical Devices Development & Compliance  for DePuy Synthes Companies (Germany - July 2019 to March 2020)
Circular BOM Project* • Creation of structures on Agile System for Bill Of Materials (BOMs).DMR Project • Data Migration Reports from Majesty ERP System to SAP/Agile Systems, for production of Medical Devices.

SOP and Documentation for Tilray (Portugal - April 2019 to Jne 2019)
• Quality Assurance review of equipment qualification documents and reports.
Review and collaboration of Design and Validation documents: URS, DQ, IQ and OQ. 

Quality Assurance Technician for Johnson & Johnson (Beers, Belgium; Schaffhausen, Germany; and Latina, Italy
(March 2018 to March 2019):
• Analysis and integration of Quality tools and documentation. 
• Writing of Product Quality Reports (PQR), Annual Periodic Review (APR),
• Continuous Processes Validation (CPV) and Key Performance Indicator (KPI).
• Tester in update of Automation Tool used for production Continuous Processes Validation (CPV) with HP ALM.
• Technologies: Amazon, Jira, SAP, SharePoint, TechSahre, DocSpace, Minitab, eLims, TIBCO Spotfire(Automation Tool) Excel, Word, HP ALM

Quality Assurance Technician for GSK  (Belgium - March 2017 to March 2018) :
• Analysis and integration of Quality tools and documentation. 
• Writing of Periodic Reviews Reports for Facilities, Equipment, Systems and Processes.
• Evaluation of qualification/validation documentation;•Review of security management, backup, restore and disaster recovery activities;•Deviations’ analysis;•Change Control analysis;•GAPs finding and CAPAs recommendation;
• Technologies:Citrix, Jira, Techshare, SAP, SharePoint, Excel, Word.	

Altran additional roles on Life Sciences Unity:
- Development of Training documentation;
- Support on Project Management documentation.

Co-Founder of Socalcos D’Ouro Project. Creation of Wines Sales Company.
Marketing and Sales Representative.

Master Degree in Biomedical Sciences at 3B’s Research Group-Biomaterials, Biodegradables and Biomimetics, Department of Polymer Engineering, Headquarters of the European Institute of Excellence of Tissue Engineering and Regenerative Medicine, University of Minho, Guimarães – Portugal

Title of Work: “Establishment of a protocol for the cryopreservation of Cell Sheets of Adipose Tissue Stem Cells”

Main skills acquired: BCA Assay, cDNA synthesis, Cell Culture (L929 cell lines and primary cells), Cell Sheet technology with human Adipose Stem Cells, Cryopreservation, Dissociation assays, Flow cytometry, Immunocytochemistry, Live/Dead assays, Microscopy, PCR, RT-PCR, RNA and Protein extraction, SDS-PAGE, Transmission Electron Microscopy (TEM), Western Blot.

Trainee on Neurobiology Department at Institute for Molecular and Cellular Biology (IBMC), Porto – Portugal

Title of Work: “Characterization of the function of PINCH1 and PINCH2 in the Central Nervous System”

Main skills acquired: BCA assays, Bradford assays, Histology, Microscopy, Immunocytochemistry, Protein extraction, SDS-PAGE, Western Blot.