Requirements: English
Company: TN Italy
Region: Ferentino , Lazio
Social network you want to login/join with:col-narrow-leftClient:Thermo Fisher ScientificLocation:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:3f55817ee794Job Views:1Posted:29.04.2025Expiry Date:13.06.2025col-wideJob Description:Analysis of the technical documentationEnsure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.Draw up Qualification/Requalification Documents (IQ-OQ-PQ Protocols), through the research and acquisition of the data and information necessary to define their contents as well as involving the corporate functions in relation to the definition of the tests they will have to carry out.QualificationEnsure the accurate qualification/requalification of plant and equipment, through the execution of the operational activities envisaged by the Protocols (IQ-OQ-PQ Protocols) and the coordination of the activities carried out by other company functions, in compliance with company protocols and SOP.Data analysisCarry out an accurate analysis of data collected during qualification activities, through the collection of data and the results generated, according to ThermoFisher Scientific protocols and standard procedures.Qualification ReportsIssue Qualification Reports (IQ-OQ-PQ Report), based on the analysis of all data recorded during validation activities, in compliance with company protocols and procedures.Archiving of qualification dossiersCarry out the accurate archiving of all documentation produced during qualification activities, issuing validation dossiers ensuring their traceability.AuditsSupport QA Compliance in preparing for and participating in audits by regulators or customers, providing necessary information and documentation. If requested by QA Compliance, and in coordination with the Supervisor, actively participate in regulatory or customer audits.For the role, the minimum requirement is:At least one year of experience in the pharmaceutical industry.#J-18808-Ljbffr