PBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.brstrongJob Description:br/strongemPrevia verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo.br/emstrongemOBJECTIVES/PURPOSE /em:br/strongulliPrimary point of contact between Quality and Automation / IT departments / Global Technical functions /liliSupport other departments including QC and Manufacturing to identify technical solutions that address data integrity requirements and provide guidance to final users /liliFoster digital innovation in regulated processes ensuring alignment with relevant regulationsbr/li /ulProvide 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 followsbrulliParticipate in DI Quality Councils, CoP and local Steering Committee /liliParticipate in Change Control assessment, including risk assessment process, as DI/IT/OT expert /liliCollaborate with Automation and IT departments to identify technical solutions that address data integrity requirements and provide guidance to final users /liliSupport the site Digitalization and Automation projects, including Agile 4.0 initiatives and Quality Roadmap /liliSupport Data Analysis and Data Management initiatives that allow agile management of quality KPI and data /liliIdentify and propose new systems and digital solutions to increase process efficiency and support paperless goals /liliSupport other departments including QC and Manufacturing to develop, execute and improve action plans by providing advice and guidance in the application of best practices /liliEnsure the application of data integrity principles in GMP processes and act as a Data Integrity Champions to promote quality culture.br/li /ulstrongTechnical/Functional (Line) Expertise:br/strongVery strong affinity to computer systems and strong knowledge of the underlying concepts of computer science and multiple certifications preferredbrulliVery strong knowledge on ITIL framework and IT/OT compliance standard /liliKnowledge of cybersecurity measures would complete the role /liliKnowledge in data management, restore and recovery processes /liliExperiences in management and execution of IT processes in regulated environmentbr/li /ulstrongemEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /em:br/strongulliTechnical degree strongpreferred: /strong in Computer Engineering, IT or equivalent. strongMandatory: /strong Studies in Cybersecurity and Data Integrity /liliAt least 5 years of experience in strongpharmaceutical: /strongIT strongQSY/IT/OT: /strong departments /liliConsolidated skills regarding the strongITIL framework: /strong, infrastructure management. /liliFluent in English and Italian /liliPreferred knowledge of Power Automatebr/li /ulstrongLeadership:br/strongulliDemonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business /liliFocuses on the few priorities and delivers superior results /liliElevates the capabilities of the organization for now and the future /liliCreates the environment that inspires and enables people to move the organization forwardbr/li /ulstrongDecision-making and Autonomy:br/strongulliExperience in Data Integrity /liliExperience in IT/OT environments /liliProblem solving attitude /liliKnowledge of GMP regulationbr/li /ulstrongInteraction:br/strongulliLocal and Global DDT and Automation teams, Laboratory contractors and vendors, regulatory authority during audit and other technical functionsbr/li /ulstrongInnovation:br/strongulliVery strong affinity to computer systems and strong knowledge of the underlying concepts of computer sciencebr/li /ulstrongComplexity:br/strongEnsure compliance with applicable regulations requirements regarding data integritybr#GMSGQbrstrongLocations:br/strongITA - RietibrstrongWorker Type:br/strongEmployeebrstrongWorker Sub-Type:br/strongRegularbrstrongTime Type:br/strongFull timebr/p #J-18808-Ljbffr