The resources operating in this area provide support in the application and the improvement of the quality system. In particular, the QA has the following tasks: Prepare and update the Quality Manual and the other SGQ documents, their release and diffusion; Collaborate to define the necessary actions for the SGQ monitoring and improvement; Verify the efficacy and the realization of the corrective and preventive actions; Handle any audit for the suppliers (general and professional services); Handle the control process on SGQ, planning the internal audits and keeping the records updated; Record the training activities of the collaborators and store the documentation. Moreover, he/she is responsible for: Preparing the standard operating procedures in order to guarantee that the clinical studies conducted by CVBF as Sponsor or CRO are conducted and the data are recorded in compliance with the protocol and with the GCP; Ensuring that the resources involved in the clinical studies are trained properly; Performing controls through internal procedures or in collaboration with external professionals on the activities and the documents related to the clinical studies and checking whether the activities have been carried out properly, and the data have been recorded, analysed and communicated in compliance with the protocol, the SOPs and the GCP; Performing controls during each phase of the data management in order to guarantee the reliability and the proper preparation of the data; The Office Managers (OMs) in Bari and Pavia are part of the QA Area and have the following tasks: Support the Direction for HR management and internal communication; Manage offices assuring availability and maintenance of facilities, hardware and software, utilities and consumables; Handle application and screening of CVs, planning interviews and providing feedback to the candidates; Guarantee to all resources appropriate work space, documents and information on the organization and its rules; Deal with all documentation related to the human resources, such as CVs, personal profiles, registries of presence; Keep the HR calendar updated with absences, missions, training courses, conferences, etc. Handle the application and the screening of the CVs, planning interviews and providing the feedback to the candidates;

Quality Assurance

The resources operating in this area provide support in the application and the improvement of the quality system. In particular, the QA has the following tasks:

Prepare and update the Quality Manual and the other SGQ documents, their release and diffusion;
Collaborate to define the necessary actions for the SGQ monitoring and improvement;
Verify the efficacy and the realization of the corrective and preventive actions;
Handle any audit for the suppliers (general and professional services);
Handle the control process on SGQ, planning the internal audits and keeping the records updated;
Record the training activities of the collaborators and store the documentation.

Moreover, he/she is responsible for:

Preparing the standard operating procedures in order to guarantee that the clinical studies conducted by CVBF as Sponsor or CRO are conducted and the data are recorded in compliance with the protocol and with the GCP;
Ensuring that the resources involved in the clinical studies are trained properly;
Performing controls through internal procedures or in collaboration with external professionals on the activities and the documents related to the clinical studies and checking whether the activities have been carried out properly, and the data have been recorded, analysed and communicated in compliance with the protocol, the SOPs and the GCP;
Performing controls during each phase of the data management in order to guarantee the reliability and the proper preparation of the data;
The Office Managers (OMs) in Bari and Pavia are part of the QA Area and have the following tasks:
Support the Direction for HR management and internal communication;
Manage offices assuring availability and maintenance of facilities, hardware and software, utilities and consumables;
Handle application and screening of CVs, planning interviews and providing feedback to the candidates;
Guarantee to all resources appropriate work space, documents and information on the organization and its rules;
Deal with all documentation related to the human resources, such as CVs, personal profiles, registries of presence;
Keep the HR calendar updated with absences, missions, training courses, conferences, etc. Handle the application and the screening of the CVs, planning interviews and providing the feedback to the candidates;