Quality Supervisor
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionThermo Fisher Scientific, world leader in serving science, is looking for a Quality Supervisor for the site in Ferentino (FR).
The resource will be responsible for the following activities:Audit and InspectionsSupport the Quality Department in preparing and actively participating in customer audits and inspections by regulatory bodies, providing necessary information and documentation. Deviations/CAPA/ChangeSupport the Quality Department in investigations related to deviations requiring technical support. Ensure that the TCS Department meets deadlines for closing CAPA and action items. Evaluate site changes for the entire TCS Department. SOPEnsure that the SOPs of the TCS group are in line with company and site quality standards. Review and/or approve the SOPs of the TCS group and related documentation. Ensure proper archiving of the documentation produced by the maintenance group (logbook). Data IntegrityEnsure that all activities of the TCS group are conducted in accordance with ALCOA+ principles and Data Integrity. Analysis of Data and Technical DocumentationReview/approve the analysis and evaluation of data and results from qualification and/or maintenance/calibration activities. Ensure the timely issuance of maintenance, calibration, and requalification activity plans and approve their contents. Personnel ManagementEnsure direction, coordination, and control of the staff structure by defining objectives, enhancing results, analyzing training and development needs to ensure a high level of performance and motivation. BudgetSupport the Supervisor in preparing and proposing the function's budget by providing necessary data and proposing budgets for the area of responsibility, in accordance with company standards. Requirements:Degree in Engineering, CTF, Biological Sciences, or similar. Proven previous experience in managing audits in the pharmaceutical field. Excellent knowledge of EU US regulations. Excellent command of the English language, both written and spoken.
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