Gvp Auditor

3 settimane fa


Lazio, Italia Arithmostech A tempo pieno

We are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.Job DescriptionPURPOSE:Manages QAS projectsfor the delivery of QA GVP services to Clients, in full compliance with theapplicable GVP Legislation, Client's requirements and the Regulatory Business QualityStandards.RequirementsACCOUNTABILITIES:Prepares and performsaudits on behalf of clients, and relevant reporting to themAssist clients insupporting their Annual Audit planCollaborate with the QADirector to manage the external Auditors and engage them as appropriateDevelops the workflowand operational planning for the QA GVP Services providedEnsures that Quality& Projects Plans, are developed according to client requirementsEnsures oversight forday-to-day interactions with all staff involved in the services deliveryDevelops standardoperating procedures and work guidance and/or reviews Client's SOPs ifapplicable, to ensure full complianceContributes to GVPquality management plans and compliance programAssists clients inaudit/inspection readinessEnsures tracking ofcompliance metricsAssistsclients in identifying and up following up on corrective action plans arisingfrom audits and inspectionsPROFESSIONAL BAKGROUND & EXPERIENCEBachelor's degree in lifescience disciplinesAtleast 5 years of experience as a GVP QA Consultant and AuditorEnglish, Very good/FluentGVP regulationsAuditing(and related qualification if required)#J-18808-Ljbffr