Adriana Amalfitano
Genzano di Roma,Roma
Profilo professionale
Regulatory Affairs Specialist figure with strong experience in a CDMO Company for Food Supplements and Pharmaceutical products.
Academic experience in the development characterization of biomaterials for biotechnologicalapplications.
Panoramica
2
2
years of professional experience
1
1
Certification
Esperienza lavorativa
Regulatory Affairs Specialist
Catalent Italy S.p.A
Aprilia, LT
2021.07 - ad oggi
- Food Supplements and Pharmaceutical products
- Control of raw materials and their compliance with current regulations through review of suppliers’ documents,
- Registration process;
- New project support;
- Manage finished product certifications;
- Participation and preparation of Customer's and regulatory inspections;
- Support to QA Operation with customer's compliant and deviations;
- Support customers for registration purposes and eCTD review
- Lead Auditor Qualification
Labeling Process Specialist
Synergie Italy, at Abbott
Roma
2020.12 - 2021.06
- Review of Labeling/Artwork for registration in new markets, area APAC/Russia-CIS
- Pharmaceutical Company
- FIXED TERM SUBORDINATION CONTRACT
Regulatory Affairs Officer
Catalent Italy S.p.A
Aprilia, LT
2019.02 - 2020.11
- INTERNSHIP AND FIXED TER CONTRACTS
- Food Supplements and Pharmaceutical products
- Control of raw materials and their compliance with current regulations through review of suppliers’ documents;
- Registration process;
- New project introduction support.
- Support QA to obtain and maintain site quality certifications
Istruzione
QUALIFICATION AS A BIOLOGIST -
University of Roma “La Sapienza”
Rome2019-07
Dottorato di Ricerca - Scienze Biomediche di base e Sanità Pubblica
Università Cattolica del Sacro Cuore
Roma2019-03
Stage Erasmus+ - Medicin and Pharmacology
University Joseph Fourier
Grenoble2015-10
MASTER’S DEGREE - MEDICAL BIOTECOLOGIES-BIOENGINEERING (LM9)
Università di Roma “La Sapienza”
Rome2015-03
THREE-YEARS-DEGREE - BIOMOLECULAR AND INDUSTRIAL BIOTECOLOGIES
Univrsità di Napoli “Federico II”
Naples2012-09
HIGH SCHOOL CLASSIC DIPLOMA - BROCCA PROJECT
State Classic High School G. De Bottis
2008-07
Competenze
- Elaboration of data and graph with Excel and use of Windows Office
- Software: PRMS, SYRS, Trackwise, Agile, SAP, JDEdwards, EDMS, ComplianceWire
- Platforms: AIFA, Eudralex, EudraGMP, Darius
- Use of GraphPad
- Instruments: Surface Plasmon Resonance (SPR), HPLC, Spectrophotometry, Dinamic Light Scattering, Optic Microscopy, Fluorescence Microscopy, Scan Electron Microscopy, UV-Vis Spectrometry, Cell culture of mammalian and bacterial cells, SDS-PAGE, Western Blot, Laboratory instruments
- Team working;
- Ability to adapt to contexts of different extractions
- Strong motivation and proactive attitude
- Precision and attention to detail
- Customer oriented
- Flexibility and adaptability
LANGUAGES
ITALIANO
Esperto
ENGLISH
Avanzato
FRENCH
Avanzato
GERMAN
Base
PUBLICATIONS
- Magazines with Impact Factor:
- Laura Chronopoulou, Adriana Amalfitano, Cleofe Palocci, Giuseppina Nocca, Cinzia Callà, Alessandro Arcovito. Biotechnol Prog. 2015 31:1381-7.
- Fracasso G, Falvo E, Colotti G, Fazi F, Ingegnere T, Amalfitano A, Doglietto GB, Alfieri S, Boffi A, Morea V, Conti G, Tremante E, Giacomini P, Arcovito A, Ceci P. J Control Release. 2016 Oct 10;239:10-8.
- Patini R., Gallenzi P., Spagnuolo G., Cordaro M., Cantiani M., Amalfitano A., Arcovito A., Callà C., Mingrone G., Nocca G. Open Dent J. Dec 2017 12;11:621-627
- Cacciotti I., Chronopoulou L., Palocci C., Amalfitano A., Cantiani M, Cordaro M., Lajolo C., Callà C., Boninsegna A., Lucchetti D., Gallenzi P., Sgambato A., Nocca G., Arcovito A. Nanotechnology 2018 Apr 10.1088/1361-6528.
- Giuseppina Nocca, Callà Cinzia, Stefano Angelo Santini, Adriana Amalfitano, Luca Marigo, Diana Valeria Rossetti, Giancarlo Spagnuolo, Massimo Cordaro. Int. J. of Analytical Chemistry 2018.
- Amalfitano A., Martini C., Nocca G., Papi M., De Spirito M., Sanguinetti M., Vitali A., Bugli F., Arcovito A. Biotechnology progress.
Disclaimer
Authorize of my personal data treatement to the senses of DL 30 june 2003, n. 196 "Code in the field of personal data protection", and GDPR – Regulation 679/2016 UE.
Certificazioni
Lead Auditor
Hobby e interessi
Science;
Reading books;
Modeling
Cronologia
Regulatory Affairs Specialist
Catalent Italy S.p.A
2021.07 - ad oggi
Labeling Process Specialist
Synergie Italy, at Abbott
2020.12 - 2021.06
Regulatory Affairs Officer
Catalent Italy S.p.A
2019.02 - 2020.11
HIGH SCHOOL CLASSIC DIPLOMA - BROCCA PROJECT
State Classic High School G. De Bottis
QUALIFICATION AS A BIOLOGIST -
University of Roma “La Sapienza”
Dottorato di Ricerca - Scienze Biomediche di base e Sanità Pubblica
Università Cattolica del Sacro Cuore
Stage Erasmus+ - Medicin and Pharmacology
University Joseph Fourier
MASTER’S DEGREE - MEDICAL BIOTECOLOGIES-BIOENGINEERING (LM9)
Università di Roma “La Sapienza”
THREE-YEARS-DEGREE - BIOMOLECULAR AND INDUSTRIAL BIOTECOLOGIES
Univrsità di Napoli “Federico II”