Work Schedule Standard (Mon-Fri) Environmental Conditions Office Join us in this outstanding experience at Thermo Fisher Ferentino site! We are looking for an investigator and client quality specialist who is able to fulfill the following requirements, in relation to the needs and indications of the Team Leader of the department: - Leads Deviations, Investigations (including complaints and non-conformities in receipt of raw materials, active ingredients and GMP materials) relating to quality issues of batches manufactured for clinical and commercial use, ensuring their completion within the encouraged timeframes; - Follow the CAPA system resulting from investigations; - Supports the preparation of periodic quality trends, intended for Management and Corporate dissemination; - Supports and actively participates in initiatives/projects in the area of Operational Excellence; - Coordinate all meetings established for new and ongoing projects; - Examines and handles Deviations and Investigations with the various company functions to define the causes and implement the corrective action plan within the timeframes set by technical agreements; - Verifies, over time, the efficiency of corrective actions; Collaborate with colleagues in prioritizing technical and management meetings with customers; - Participates in customer visits and quality inspections (Audit) and internal and regulatory inspections; - Generates reports on quality events; - Work in achievement of objectives for the part of their competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives; - Gives to the achievement of Business/customer objectives; - Collaborates with Compliance colleagues in reviewing and drafting System SOPs that fall within the scope of the Quality Unit to which they belong; - Participates in the drafting of FMEAs; - Deals with the drafting, archiving, distribution of controlled company documentation; - Trains personnel involved in PDS/DPS quality activities; - In accordance with the instructions and scheduling of activities by the manager, they look after drafting the QATs and discuss them with the Clients, the site QPs and the lawyer. - They act as SME and QO referent for the assigned projects, representing the reference quality figure and support for Customers and internal departments in order to guarantee the success of the projects and the manufacturing/disposition of GMP batches. - They support the team and other functions in ensuring full support for the Readiness and BUs processes. This is an excellent opportunity for your career growth