Lisa Stefani

Quality Assurance "FINISHED PRODUCTS RELEASE" Associate at Kedrion Biopharma
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Lucca, Tuscany, Italy, IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Cambridge Business English Certificate (=BEC) Vantage
    Cambridge Assessment International Education
    Jan, 2016
    - Nov, 2024
  • Iscrizione all' Ordine Nazionale dei Biologi
    Ordine Nazionale dei Biologi
    Sep, 2015
    - Nov, 2024

Experience

  • Kedrion Biopharma
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Assurance "FINISHED PRODUCTS RELEASE" Associate
      • Sep 2015 - Present

      > Production Batch Records Review (pooling, fractionation, purification, filling, visual check and packaging).> In-Process Controls Analyses Review during production. > Regulatory Compliance and regular cooperation with Regulatory Affairs to prepare the required QA Documentation for Marketing Authorisation and Finished Products Release.> Finished Products Release > AIFA and FDA Competent Authorities Inspections.> Current-Good Manufacturing Practices (=c-GMP) and Quality Standard Operating Procedures (=SOP) implementation supported by training to all Personnel involved.> Deviations Management and Monitoring on semi-finished and finished products. Show less

    • Quality Assurance "PLASMA RAW MATERIAL RELEASE" Associate
      • Mar 2006 - Aug 2015

      > Plasma raw material documentation from Italian and European Plasma/Blood Facilities which have to comply and be reviewed, according to law requirement, in order to be released for production (fractionation and viral inactivation processes).> Management of Plasma raw material deviations impacting on collection, transport, acceptance, storage, documentation and physical check of plasma raw material to be solved for the release to production.> Plasma raw material Deviations Reports shared with Italian/European Plasma and Blood Facilities.> Technical Quality Agreements with Plasma Raw Material Suppliers and Warehouses. > Second-Part Audit to Italian and European Plasma Suppliers according to law requirements and current Good Manufacturing Practices. > First-Part Internal Audit according to c-GMPs requirements> AIFA and FDA Competent Authorities Inspections. Show less

  • SGS
    • Switzerland
    • Professional Services
    • 700 & Above Employee
    • Quality Auditor
      • Jun 2005 - Feb 2006

       Second-Part Quality Audit, on behalf of SGS Italia S.p.A., at Pastificio Fabianelli S.p.A. in Castiglion Fiorentino (Province of Arezzo) to verify the compliance between the Company Production Standards and the contractual requirements of the Arab Customer "QUAL PRO – AL ALALI".  Second-Part Quality Audit, on behalf of SGS Italia S.p.A., for "MYSTERY SHOPPING- FIAT" Program at FIAT, LANCIA and Alfa Romeo Dealerships, located in Tuscany (Italy). Audit focused on verifying the compliance between the Dealers and final customers. Show less

  • Sinergest S.r.l.
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Quality Management System Consultant
      • Jan 2004 - May 2005

       Consulting for food and non-food companies for the implementation of certifications: UNI EN ISO 9001, UNI 10939, UNI 11020, BRC- Global Standard Food, IFS-International Food Standard.  Quality Manual, procedures/operating instructions Implementation for food and non-food companies, with their practical applications and training courses for the Staff involved.  European and national law requirements (HACCP, EC laws/regulations) consulting concerning the Food sector and related practical implementations.  First-Part and Second-Part Audit in Food companies according to HACCP requirements and ISO 9001, BRC and IFS certification Standards. Show less

Education

  • Università di Pisa
    Laurea Magistrale LM, Biologia/Scienze biologiche, generale

Community

You need to have a working account to view this content. Click here to join now