Client and Regulatory Audit Specialist will be responsible for following activities :
Execution of external quality audits, preparation of the Capa plan and verification of the completion of the activities deriving from the observations;
Execution of Surveillance activities in preparation for Customer, Corporate and Regulatory Audits;
Follow-up of compliance activities deriving from external audits;
Handling of CAPA system resulting from observations raised from external audits;
Editing, archiving, distribution of controlled company documentation;
Preparation of KPIs and quality metrics, intended for company management;
Support in the management of investigations related to quality issues;
Support for PPI initiatives.
Furthermore, in relation to the Quality Compliance Department needs and according to the indications of the Quality Compliance Manager, Client and Regulatory Audit Specialist will support for following activities :
Handling of Product complaints, related to manufactured lots for commercial use with definition of the contingent solutions and action plans that avoid the recurrence of the event;
Issuing of the Annual Product Review;
Execution of internal quality audits, preparation of the report and verification of the completion of the activities deriving from the observations;
Execution of supplier quality audits for their qualification, preparation of reports and traceability of the completion of compliance activities;
Supervision on the quality of supplies and interface with Purchases and suppliers;
Maintenance of the status of qualification of Suppliers and management of Supplier Compliance activities;
Maintenance of Regulatory compliance on excipients, primary packaging materials, components and materials used during the production process (e.
g. filters, bags) or simulations, where applicable (e.g. cleaning products, emollients and lubricants, sectors of crop and spare equipment);
Handling of the CAPA system resulting from observations raised during internal audit or coming from complaint investigations.