Summary
Overview
Work History
Education
Skills
Personal Information
Timeline
Generic
SARA BASSANI

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
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.
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)
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
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
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, Italy
11-2024

Certificate of Competence - EN ISO 13485:2016/A11:2021

TV Italia S.r.l
Milan, Italy
11-2024

Webmaster Course - Website Design

ENAIP
Varese, Italy
09-2009

Laurea Magistrale - Biological Sciences Pathophysiological Specializat

Università Degli Studi Di Milano
Milan, Italy
05-2003

Diploma Di Maturità Scientifica - Scientific

Liceo Scientifico Di Gallarate
Gallarate, Italy
06-1996

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

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SARA BASSANIQA/RA Officer