Arithmostech
Verona/Milano/Roma, Italy | Posted on 13/09/2023 We areBusiness and Technology experts in the Life Sciences industry. We are along-standing Partner and Service Provider across Clinical Development,Regulatory and Compliance, Quality Management, Pharmacovigilance, and MedicalAffairs domains. We helppharmaceutical, biotechnology, nutraceutical, medical device, universities,hospitals and non-profit organisations to gain the best business value throughtechnology-enabled solutions and achieve excellence in business operations. Job Description PURPOSE: Supports the CSVManager in all aspects of the Company Integrated Management System. Ensures that computer systems are properlyvalidated and maintained in a compliance status, through appropriate changecontrol management and periodic review. Requirements ACCOUNTABILITIES: Cooperate with CSVManager and relevant stakeholders for the validation of information systems bymanaging and coordinating the drafting of Validation Plans, User RequirementSpecifications, Functional and Design Specifications, GxP Risk Assessment, TestingProtocols (IQ / OQ / PQ), User Acceptance Testing, Traceability Matrix andValidation Reports. Support and monitor thecorrect management of Change Control of validated computerized systems Cooperate with CSV OperationManager and relevant stakeholders for the maintenance of the validation statusof the systems by implementing the Periodic Review procedures Support resolution ofsystem deviations/errors and management of CAPAs related to information systemsin accordance with quality requirements and GxP Ensure that the systemscomply with regulatory requirements Participate in theaudits relative to Computer System Validation Conduct internal/externaltrainings in Computer System Validation area Tocollaborate in the definition of CSV SOPs, WIs, guidelines and best practices BACKGROUND & EXPERIENCE Bachelor Degree in ComputerScience, Engineering,LifeSciences/Biomedical matters or Scientific Area Atleast 2/3 years of experience as CSV specialist in Life Science/Health industry KNOWLEDGE MS Office package Knowledge of CSV regulationsand guidelines (21CFR part 11, Annex 11, GAMP5) Knowledge of pharma processesand GxP regulations (mainly GCP, GVP) Knowledge of risk management principles Basic Knowledge of ISO/IEC27001:2013 and of ISO 9001:2015 BasicKnowledge of computer information applicable regulation J-18808-Ljbffr
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