Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Thermo 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 Inspections Support the Quality Department in preparing and actively participating in customer audits and inspections by regulatory bodies, providing necessary information and documentation.Deviations/CAPA/Change Support 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.SOP Ensure 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 Integrity Ensure that all activities of the TCS group are conducted in accordance with ALCOA+ principles and Data Integrity.Analysis of Data and Technical Documentation Review/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 Management Ensure 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.Budget Support 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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