Quality assurance

Internal Audit: perform checks for validation activities in order to promote preventive actions and corrective actions (CAPA) to remedy the causes of deviations or product recall.
QA VAL: review and approval of validation protocols and reports of manufacturing processes and systems (design qualification - installation and operational qualification - performance qualification - process validation - cleaning).
Change requests and deviations: management and quality impact evaluation.
Technical Writing: Standard Operating Procedures, Technical Reports and Risk Assessment. 
Key Performance Indicators: providing detailed reports of analyses in order to be used for remediation projects; 
Regulatory agencies: experience with FDA and AIFA inspections.

Work in all aspects of automation and validation of industrial equipment and qualification projects. Support installation of pharmaceutical equipment - Writing and executing of Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Writing and review of Standard operating procedure (SOP), Technical Assessment, GAP analysis.  Complies with cGMP, safety requirements, and company policies.
Major Projects:
•	Qualification Consultant per Philips Morris International (Greece) in collaboration with CAI: 
supporter for primary qualification activities (one month);
•	Qualification Consultant per Philips Morris International (Bologna) in collaboration with SGS: 
supporter for secondary qualification activities (one year);
•	Qualification and QA Consultant per CapuaBioServices (Capua) :
as independent worker in managing all aspects of projects (2 years);
•	Qualification and QA Consultant per Zoetis (Catania): 
as occasional support.

Training program to acquire thorough knowledge of current methods used in the production and control of medicinal products and their distribution, Good Manufacturing Practices (GMP), industrial management systems, evaluation of product cost as well as rules governing drug registration, manufacture and documentation.
Thesis: "Quality Systems Development within Aseptic Production: normative and operational aspects, continuous process verification”. Analysis of ISO and GMP for aseptic production management: classification of areas, environmental monitoring, validation of systems and processes, continuous improvement.