Orari di ricevimento
appuntamento con il docente via email
Curriculum
Work Experiences
Date: January 2017 – Present
Function: Qualified Person / Quality Director
Mission:
To lead and manage the strategic and operational performance of the Quality Unit, ensuring the Regulatory and Customer Compliance.
Ensuring the activities of monitoring and keeping of the management of quality system and thus advancing the improvement activities of quality system management.
Ensuring the compliance of the manufactured products to both current regulations (EU GMP Part I) and common technical document (CTD).
To manage the external audit of both Regulatory Agencies and clients (about 10 audit per year)
Responsible Person for the management of “narcotic” production
Responsible Person for the management of “food supplement” production
Furthermore, to lead and manage the strategic and operational performance of the R&D Department pf ITC Farma, ensuring the projects of our clients (such as multinational company and university).
Company: ITC FARMA/ITC PRODUCTION - Via Pontina Km 29, 00071 Pomezia (RM) - Italia
Activity Area: Pharmaceutical Company
Date: September 2014 – December 2016
Function: Qualified Person / Quality Assurance Manager
Main activities and Responsabilities:
Ensuring the activities of monitoring and keeping of the management of quality system and thus advancing the improvement activities of quality system management.
Ensuring the compliance of the manufactured products to both current regulations (EU GMP Part I) and common technical document (CTD).
Ensuring the qualification of suppliers, including the plan and execution of audit to evaluate and monitor the quality system and the reliability of the suppliers.
Ensuring the self-inspections and thus verify and monitor the status of compliance of all the Departments
Review of the SOPs and the quality documents (batch records, validation protocols and reports, quality technical agreements, etc.)
Review of the SOPs, ensure and monitor the management of the documentation compliance
Supervising the development and transfer processes (review/drawing up of the master batch records, validation and stability protocols and reports, supervise of IQ/OQ/PQ of the processes, including equipment, facilities and utilities)
Ensuring the compliance of the products/processes to the current regulations and to client requests
Ensuring the management of the complaints
Ensuring the management of the non conformities and corrective/preventive actions
Ensuring the management of change control
Drug & Formulation Development
Collaborate with public and private on clinical trials
Company: ITC FARMA - Via Pontina Km 29, 00071 Pomezia (RM) - Italia
Activity Area: Pharmaceutical Company
Date: April 2013 – September 2014
Function: Quality Assurance Coordinator
Main activities and Responsabilities:
Coordinating the activities of monitoring and keeping of the management of quality system and thus advancing the improvement activities of quality system management.
Ensuring the compliance of the manufactured products to both current regulations and common technical document
Coordinate the qualification of suppliers, including the plan and execution of audit to evaluate and monitor the quality system and the reliability of the suppliers.
Coordinating and carrying out the self-inspections and thus verify and monitor the status of compliance of all the Departments.
Review of the SOP and the quality documents (batch records, validation protocols and reports, quality technical agreements, etc.)
Review of the plant SOP, ensure and monitor the management of the documentation compliance
Anayzing the development and transfer processes (review/drawing up of the master batch records, validation and stability protocols and reports, supervise of IQ/OQ/PQ of the processes, including equipment, facilities and utilities)
Ensuring the compliance of the products/processes to the current regulations and to client requests
Ensuring and coordinating the management of the complaints
Ensuring and coordinating the management of the non conformities and corrective/preventive actions
Coordinating the management of change control
Drug & Formulation Development
Collaborating with public and private on clinical trials
Company: ITC FARMA - Via Pontina Km 29, 00071 Pomezia (RM) - Italia
Activity Area: Pharmaceutical Company
Date: May 2011 – March 2013
Function: Laboratory Quality Control Supervisor
Main activities and Responsabilities:
Drawing up, update and review of SOP (Standard Operative Procedure) regarding analysis of raw materials, bulk, intermediates, finished products and retests.
Drawing up, update and review of SOP for the management, use and periodic control (calibration verification, IQ/OQ/PQ, revalidations) of equipment, facilities and utilities under the responsibility of QC Department
Training
Monitoring and review analysis of the climatic chambers under the responsibility of QC Department
Management of non conformities (OOS and OOT)
Management of change controls
Software and analytical Validation
Drug Development
Supervise the activities of sampling (API, excipients, packaging materials and intermediates)
Supervise the orders of reagents, solvents and consumables of QC Department
Supervise the activities of the laboratory analysts
Supervise the results of analysis
Company: ITC FARMA - Via Pontina Km 29, 00071 Pomezia (RM) - Italia
Activity Area: Pharmaceutical Company
Date: November 2010 – April 2011
Function: Stage QA Compliance&Services
Main activities and Responsabilities:
LEAN optimization of validation of supplier process of raw materials , packaging materials and services
Review of the Supplier Vendor Scoring according to the annual KPI (Key Performance Indicators);
Drawing up and updating of Site Validation Master Plan
Review of SOP regarding all the suppliers
Company: Abbott S.r.l. - Via Pontina Km 52, 04010 Campoverde di Aprilia (LT) - Italia
Activity Area: Pharmaceutical Company
Education and training:
Hospital Pharmacy Graduate School: from 2020 at present
Degree: July 2010 - Pharmaceutical Chemistry and Technology - voto 110/110 - Licensed Pharmacist
"La Sapienza" University , Rome – Italy
ISO 9001:2015 Auditor Certificate; GMP Part I and Part II Auditor Certificate; Project Management Prince 2 Foundation course; English course in Oxford EF-school; Extractables & Leachables course; Work Safety course (D.lgs. 81/08 e s.m.i.);
Languages
Mother tongue: Italian
Other languages: English
UNDERSTANDING: Ascolto: C1 Lettura: C1
WRITTEN: C1
SPOKEN: C1
Skill Profile:
Capable of management working groups, with excellent organizational abilities. I am resourceful, with group work skills and problem-solving skills. I am customer service-oriented, accustomed to working under pressure and dealing with work and clients’ needs. I am computer literate. I am willing to travel. I have a clean driving license.
Technical Profile
Ensure that all staff are appropriately trained to meet the job specific requirements of their role. Bringing complex changes into effect. Communicating and influencing at all levels. Practical knowledge of quality and auditing systems. Willing to travel and open to the idea of relocation. Experience working closely with the Quality Management System (QMS). Working knowledge of Eu GMP Part I and II. Active member of AFI and GIF groups.
Member of Department Board of Pharmaceutical Chemistry and Technology "La Sapienza" University.
Professor of Pharmaceutical Chemistry Applied at "La Sapienza" University
Scientific Publications
Appropriatezza prescrittiva e d’uso degli inibitori di pompa protonica in un’Azienda Sanitaria del Lazio – pubblicato su ISSN 0393-5620 ISTISAN Congressi 24/C6 ottobre-dicembre 2024 (n. 4) 1° Suppl. - Arenare Loredana, di Manno Gianluca, Vellucci Angela, Ammendola Debora, di Manno Stefano -
Eparine a basso peso molecolare brand vs biosimilare: Analisi dell’appropriatezza prescrittiva tra normativa e canali distributivi - Arenare Loredana, di Manno Gianluca, Vellucci Angela, Ammendola Debora, di Manno Stefano, Viscido Fabio - - pubblicato su ISSN 0393-5620 ISTISAN Congressi 24/C6 ottobre-dicembre 2024 (n. 4) 1° Suppl.