Client & Regulatory Specialist (Senior)
Thermo Fisher Scientific, Inc.
Ferentino, Italy
4 gg fa

Job Description

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.
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