Sara Cartella

Biography

  Quality Assurance Specialist at Mylan Italy onsolidated and expanded my knowledge in several quality assurance field, ranging from Quality System Management to monitoring, management and interaction with Third-party manufacturers. I supported the Company for local implementation of Business Quality SOPs acquiring high knowledge in terms of quality and business Improvement.  In line with conformity and effectiveness requirements of Quality Management System, I experienced internal and external audit with high focus on Gap analysis implementation, Remediation plan and Corrective and Preventive Action (CAPA) emerged also from Self-Assessment activities.  Furthermore, the experience in a Distribution Company allowed me to have close relations with Medical Device manufacturers, carrying out intermediary roles among associates, local warehouse and customers through the management of Field Safety Notice (FSN/FSCA) and product stop-shipment. The opportunity to work in a Pharmaceutical Company gave me the chance to deepen processes strictly related to Drug Products, from the manufacturing process to activities on products already distributed to the market. Thanks to my work experience at different multinational companies, I had the opportunity to work with people from different cultures. This allowed me to improve my relationship skills and my attitude to be very successful in team-working.  Elaboration and Management of Raw Material, Finish product and Packaging Specifications according to Regulatory requirements and Pharmacopoeia.  - Management of Global Quality documentation according to Regulatory Notification by Electronic Document Management System. - Business Administrator of Electronic Document Management System. - Management of Third-Party Manufacturer (TPMs) including the following activities: Review/Update/Implementation of Quality Technical Agreement (QTA) between Mylan and TPMs - Management of Annual Product Quality Review (APQR) related to Mylan products manufactured by TPMs - Management of Status Information Report provided by Regulatory Assurance team - Management of Changes issued by TPMs, starting from the Change Request (CR) until the implementation at the manufacturer - Management of Complaints through TrackWise System - Internal and external audit at the Manufacturer site. - Management of Corrective and Preventive Action (CAPA) at manufacturer sites - Management Critical Events at Manufacturing sites - Management of process deviations and deviations from procedures, specifications and registered documents.

Research Interest

- Internal and external audit at the Manufacturer site. - Management of Corrective and Preventive Action (CAPA) at manufacturer sites - Management Critical Events at Manufacturing sites