Ph3bJob Description /b /h3 pbOBJECTIVES/PURPOSE /b /p ul lipPrimary point of contact between Quality and Automation / IT departments / Global Technical functions /p /li lipSupport other departments including QC and Manufacturing to identify technical solutions that address data integrity requirements and provide guidance to final users /p /li lipFoster digital innovation in regulated processes ensuring alignment with relevant regulations /p /li /ul pProvide oversight of GxP computerized system activities and documents to confirm that computerized systems comply with regulatory requirements and Takeda procedures for data integrity and IT/OT compliance, as follows: /p ul lipParticipate in DI Quality Councils, CoP and local Steering Committee /p /li lipParticipate in Change Control assessment, including risk assessment process, as DI/IT/OT expert /p /li lipCollaborate with Automation and IT departments to identify technical solutions that address data integrity requirements and provide guidance to final users /p /li lipSupport the site Digitalization and Automation projects, including Agile 4.0 initiatives and Quality Roadmap /p /li lipSupport Data Analysis and Data Management initiatives that allow agile management of quality KPI and data /p /li lipIdentify and propose new systems and digital solutions to increase process efficiency and support paperless goals /p /li lipSupport other departments including QC and Manufacturing to develop, execute and improve action plans by providing advice and guidance in the application of best practices /p /li lipEnsure the application of data integrity principles in GMP processes and act as a Data Integrity Champion to promote quality culture. /p /li /ul pbTechnical/Functional (Line) Expertise /b /p pVery strong affinity to computer systems and strong knowledge of the underlying concepts of computer science and multiple certifications preferred /p ul lipVery strong knowledge on ITIL framework and IT/OT compliance standard /p /li lipKnowledge of cybersecurity measures would complete the role /p /li lipKnowledge in data management, restore and recovery processes /p /li lipExperiences in management and execution of IT processes in regulated environment /p /li /ul pbEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /b /p ul lipTechnical degree bpreferred /b in Computer Engineering, IT or equivalent. bMandatory: /b Studies in Cybersecurity and Data Integrity /p /li lipAt least 5 years of experience in bpharmaceutical /b IT bQSY/IT/OT /b departments /p /li lipConsolidated skills regarding the bITIL framework /b, infrastructure management. /p /li lipFluent in English and Italian /p /li lipPreferred knowledge of Power Automate /p /li /ul pbLeadership /b /p ul lipDemonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business /p /li lipFocuses on the few priorities and delivers superior results /p /li lipElevates the capabilities of the organization for now and the future /p /li lipCreates the environment that inspires and enables people to move the organization forward /p /li /ul pbDecision-making and Autonomy /b /p ul lipExperience in Data Integrity /p /li lipExperience in IT/OT environments /p /li lipProblem solving attitude /p /li lipKnowledge of GMP regulation /p /li /ul pbInteraction /b /p ul lipLocal and Global DDT and Automation teams, Laboratory contractors and vendors, regulatory authority during audit and other technical functions /p /li /ul pbInnovation /b /p ul lipVery strong affinity to computer systems and strong knowledge of the underlying concepts of computer science /p /li /ul pEnsure compliance with applicable regulations requirements regarding data integrity /p h3bLocations /b /h3 pITA - Rieti /p h3bWorker Type /b /h3 pEmployee /p h3bWorker Sub-Type /b /h3 pRegular /p h3bTime Type /b /h3 pFull time /p /p #J-18808-Ljbffr