SARA BASSANI
QA/RA Officer
Cavaria con Premezzo
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
In addition, hardworking and passionate job seeker with strong organizational skills eager to secure entry-level QA & RA Officer position. Ready to help team achieve company goals.
Overview
2025
2025
years of professional experience
10058
10058
years of post-secondary education
2
2
Languages
Work History
Technical Documentation Officer
DIA.PRO Diagnostic Bioprobes S.r.l
Sesto San Giovanni, Italy
02.2024 - Current
- Prepares or updates the Technical Product File (Design Dossier, Risk Analysis, Essential Requirements, labels, other technical and process documents) in accordance with the specific procedure of the SdQ and the requirements defined by the IVD Directive 98/79/EC.
- Collaborates with the Regulatory Affairs in the completion of the registration practices of IVD products in the various countries, in the drafting and updating of technical documents, under the supervision of RS AR.
- Carries out Internal Audit in accordance with the plans defined by the Management (CEO) and under the management of the RSAQ to which it reports.Collaborated with quality assurance team to comply with regulatory requirements.
- Collaborated with quality assurance team to comply with regulatory requirements.
- Intervenes in emergencies or needs in production processes that require extraordinary manual skills.
Laboratory Technician
DIA.PRO Diagnostic Bioprobes S.r.l.
Sesto San Giovanni, MI
1 2007 - 01.2024
- Development and production of immunodiagnostic systems in ELISA and Chemiluminescence (CLIA) by bioconjugation of magnetic microparticles, applied to an automated Dia.Pro instrument (S.A.R.A), with particular attention to the development and production of diagnostic kits for the determination of antibodies against the Spike antigen of the Covid-19 Virus (SARS-CoV-2) in human serum and plasma
- Analysis of the quality of strategic reagents and components according to Operating Procedures and of the quality of finished kits according to the 'Batch Release' document according to the production plan
- Tests for quality control of raw materials, semi-finished and finished products
- Collaboration for the correct identification of the components of a production batch before their delivery for sorting and packaging operations
- Compilation of Batch Release documentation and related processes
- Ability to fill in Technical Documents and related forms, in adherence to the company QMS
- Verification of compliance for the requirements defined by the In-vitro Diagnostic Directive
- Drafting of the Technical Product File
- Transfer of technology and documentation to the Production Department of the developed product
- Collaboration with external centers and R&D groups in joint projects and joint ventures
- Knowledge of safety regulations, with particular care in following strict safety protocols and using personal protective equipment (PPE
- Organization and maintenance of laboratory instruments and equipment (calibration, cleaning, sterilization and conducting periodic tests to verify the perfect efficiency and precision of the instrumentation)
- Use of precision pipettes, spectrophotometers, centrifuges, PH-meter, mixers, sonicator, magnetic separator, precision balances, automatic instrumentation for test development
Laboratory Assistant
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS (CHUV)
Losanna
01.2008 - 01.2009
- Research laboratory of the Department of Cardiovascular Surgery
- Studies of the effects of chronic and intermittent hypoxia on the animal model (rats)
- In vivo operations on rats for the extraction of heart and lungs
- Electrophoresis, western blotting, protein extraction and dosing techniques
- Excel analysis of the data obtained and bibliographic searches on the interne
R&D Laboratory Technician
BIO.RAD LABORATORIES GmbH
Monaco di Baviera
01.2006 - 01.2007
- Pharmaceutical company: immunochemistry and pharmaceutical biotechnology
- Development and verification of an analytical method for the monitoring of a therapeutic neuroleptic drug
- Use of HPLC instrumentation
- Analytical study of data in Excel
R&D Laboratory Technician
EQUIPAR DIAGNOSTICI SRL
Saronno, Varese
01.2003 - 01.2005
- Chemical-pharmaceutical company: production of immunodiagnostics for infectious diseases and cancer
- Development and development of ELISA and chemiluminescence immunological diagnostic kits for the diagnosis of infectious diseases and tumors
- Ability to work independently and also in teams in collaboration with the production and quality control departments
Education
Certificate of Competence - Internal Auditor of Quality Management Systems: Sp
TV Italia S.r.l
Milan, Italy11-2024
Certificate of Competence - EN ISO 13485:2016/A11:2021
TV Italia S.r.l
Milan, Italy11-2024
Webmaster Course - Website Design
ENAIP
Varese, Italy09-2009
Laurea Magistrale - Biological Sciences Pathophysiological Specializat
Università Degli Studi Di Milano
Milan, Italy05-2003
Diploma Di Maturità Scientifica - Scientific
Liceo Scientifico Di Gallarate
Gallarate, Italy06-1996
Skills
Good knowledge of Word and ExcelGood use of internet browsers and email management
Personal Information
Date of Birth: 05/06/76
Timeline
Technical Documentation Officer
DIA.PRO Diagnostic Bioprobes S.r.l
02.2024 - Current
Laboratory Assistant
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS (CHUV)
01.2008 - 01.2009
R&D Laboratory Technician
BIO.RAD LABORATORIES GmbH
01.2006 - 01.2007
R&D Laboratory Technician
EQUIPAR DIAGNOSTICI SRL
01.2003 - 01.2005
Laboratory Technician
DIA.PRO Diagnostic Bioprobes S.r.l.
1 2007 - 01.2024
Certificate of Competence - Internal Auditor of Quality Management Systems: Sp
TV Italia S.r.l
Certificate of Competence - EN ISO 13485:2016/A11:2021
TV Italia S.r.l
Webmaster Course - Website Design
ENAIP
Laurea Magistrale - Biological Sciences Pathophysiological Specializat
Università Degli Studi Di Milano
Diploma Di Maturità Scientifica - Scientific
Liceo Scientifico Di Gallarate