As per hierarchical organization, the teams that report directly to me are: PD & production of IMP teams, QC & QA teams, for a total of 35 people;Main activites:Interface with customers in collaboration with Scientific Directors & QP to coordinate and resolve their needs;Ensure that an effective quality management system is in place to achieve the quality objectives;Ensure that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organization;Establish a quality policy that describes the overall intentions and direction of the company related to quality and ensure continuing suitability and effectiveness of the quality management system and GMP compliance;Ensure that each batch has been manufactured and analyzed in accordance with the Product Specification File, the principles and guidelines of the EC GMP or the GMP of a third country recognized as equivalent under a mutual recognition agreement and any other relevant legal requirement;Require observance of EH&S rules and usage of the individual means of protection, by all the interested personnel;Ensure that the Production, Quality Control & Quality Assurance documentation and records are reviewed and signed by the authorized persons;Collaborate with Engineering & Maintenance Unit Head, Scientific Director, QP in order to assure that the design, construction, installation and qualification of new facilities, equipment, system the agreed times and costs are observed;Ensure protection of intellectual property and sensitive corporate data;Manage with direct reports each customer order and each internal project included the relevant FTEs allocation in order to assure the respect of the budgets and timelines agreed;In this role I report directly to the Scientific Director and QP of Advent.In addition, I maintain also, the certification as QP (Deputy), as per art. 51 of Direttive 2001/83/EEC, and Dlg.vo 219.

Management of issues, risks and project change requests to ensure successful and on-time NPI/TT project delivery (Liquid Injectable products in vials, pre-filled syringes and ampoules; β lactam antibiotics solid Injectable products in vial & pre-filled syringes and β lactamic antibiotics solid oral hard capsules and tablets). Procure adequate resources to achieve project objectives in planned timeframes.Manage the day-to-day project activities and lead the team, ensure that projects and programs are proceeding according to scope, schedule, budget and quality standards.Provide status reporting regarding project milestones, deliverable, risks, issues, project success criteria results & metrics, communicating across key stakeholders, project team, sponsors, CEO.Act, also, as an internal quality Advisor for the project.Establish practices, templates, policies, tools, and partnership to expand the capabilities of the Group.In this role I report directly to the Vice President of Quality and Technical Operations.In addition, I maintain also, as Deputy QP for Injectalia site, the role of Qualified Person as per art. 51 of Direttive 2001/83/EEC, and Dlg.vo 219.

Qualified Person as per art. 51 of Direttive 2001/83/EEC, and Dlg.vo 219;Check that each product has been manufactured and controlled according to cGMP and Direttive 2003/94/CE before proceed to certificate and release (Liquid Injectable products in vials, pre-filled syringes and ampoules);Lead the ispection on site of all regulatory agencies as AIFA & FDA, and all customers audit;Guarantee that manufacturing processes and analytical processes are validated and that all needd quality checks and tests are executed and the batch record review is positively closed;Assure that all OOS, deviations and change control eventually occurred, are conveniently tracked and managedAs Quality Assurance Manager, according to what expected from the EU Guidelines for GMP Vol 4 Chapter 2, assure:issuing of procedures and of all the other quality documents;production and laboratory areas environmental monitoring and also the hygiene of whole factory;process validation & equipment/utilities & facilities qualification execution;personnel training plan execution;suppliers & materials approval flow execution, audit & monitoring; deviation, not conformity, OOT, OOS and change control management;batch record review;PQR, self-audit, quality KPI management;documentation storage;reference & retention samples and materials & products storage in expected conditions;in general that all is managed with respect of cGMP.

Coordination and management of PMO resources and PMO leading;as Project Manager for new products introduction, from the quotation phase, through the development study (definition of the formulation, feasibility trial in laboratory), the production preliminary trial, the stability study (physical and chemical) up to the launch industrial batch, for the three lines of business (Pharmaceutical, Nutritional and Cosmetics), responsible of:managing and coordinating the NPI projects quotation & implementation process;NPIs excellence methodology and tools application; project planning (timelines);assuring completion/management of costs and resources for each project;resources monitoring for NPI projects in R&D and for all the other departments activities & workload; budget and forecast management for all development and quality fees revenues;communication and stakeholder management, leading cross functional teams, not direct reports, project meetings, & motivating members, throughout project lifecycle;manage launch activities to ensure availability of finished product to meet the customer expectations in terms of timing and reliability of deliverables;establishing and monitoring KPIs for NPIs (new product introduction) flow for roadmap corporate project;providing regular and structured reporting and follow up to senior management & Corporate Innovation & R&D group;being the main interface towards Corporate Innovation & R&D group, Business Development Group, customers for NPD projects.In this role I report directly to the Global Project Management VP

Management of Change Control relevant to systems/equipments;Management and supervision of Qualification plans of systems/equipments, Process Validation and Cleaning Validation plans;Review and approval of Technical and Functional Specifications and User Requirements (Systems, equipments), of standard procedures relevant to equipment and processes qualification & validation, site master file (SMF), validation master plan (VMP), cleaning validation master plan CVMP, Qualification Protocols and Report of systems/equipments, commissioning e start-up, FAT,SAT, IQ, OQ, PQ and of Process Validation Protocols and Report;From January 2011: Member of the Catalent Validation Center of Excellence: the goal of this international team was to establish best practice processes and procedures and update current quality policies and operational procedures for roll-out to all Catalent sites.From March 2011: Leader of the Validation Committee of Aprilia: a cross functional team; the goal of this Site-cross team was to define the validation policies to assure a continuous alignment to the regulatory requirements for Cosmetics, Nutritional and Pharmaceutical production.

the company is authorized to the production, packaging and control of -lactamic Penicillin and Cephalosporin antibiotics in oral and Injectable forms.