It Quality System Expert

Job Description Previa verifica dei requisiti professionali, costituisce titolo preferenziale l'appartenenza alle Categorie Protette ai sensi dell'art 1 L. ***** 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. OBJECTIVES/PURPOSE - Primary point of contact between Quality and Automation / IT departments / Global Technical functions - Support other departments including QC and Manufacturing to identify technical solutions that address data integrity requirements and provide guidance to final users - Foster digital innovation in regulated processes ensuring alignment with relevant regulations - Provide 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: - Participate in DI Quality Councils, CoP and local Steering Committee - Participate in Change Control assessment, including risk assessment process, as DI/IT/OT expert - Collaborate with Automation and IT departments to identify technical solutions that address data integrity requirements and provide guidance to final users - Support the site Digitalization and Automation projects, including Agile 4.0 initiatives and Quality Roadmap - Support Data Analysis and Data Management initiatives that allow agile management of quality KPI and data - Identify and propose new systems and digital solutions to increase process efficiency and support paperless goals - Support other departments including QC and Manufacturing to develop, execute and improve action plans by providing advice and guidance in the application of best practices - Ensure the application of data integrity principles in GMP processes and act as a Data Integrity Champions to promote quality culture. Technical/Functional (Line) Expertise - Very strong affinity to computer systems and strong knowledge of the underlying concepts of computer science and multiple certifications preferred - Very strong knowledge on ITIL framework and IT/OT compliance standard - Knowledge of cybersecurity measures would complete the role - Knowledge in data management, restore and recovery processes - Experiences in management and execution of IT processes in regulated environment EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS - Technical degree preferred in Computer Engineering, IT or equivalent. Mandatory: Studies in Cybersecurity and Data Integrity - At least 5 years of experience in pharmaceutical IT QSY/IT/OT departments - Consolidated skills regarding the ITIL framework, infrastructure management. - Fluent in English and Italian - Preferred knowledge of Power Automate - Leadership – Demonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business; Focuses on the few priorities and delivers superior results; Elevates the capabilities of the organization for now and the future; Creates the environment that inspires and enables people to move the organization forward - Decision-making and Autonomy – Experience in Data Integrity, Experience in IT/OT environments, Problem solving attitude, Knowledge of GMP regulation - Interaction – Local and Global DD&T and Automation teams, Laboratory contractors and vendors, regulatory authority during audit and other technical functions - Innovation – Very strong affinity to computer systems and strong knowledge of the underlying concepts of computer science - Complexity – Ensure compliance with applicable regulations requirements regarding data integrity #GMSGQ #LI-LA1 Locations: ITA - Rieti Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time #J-18808-Ljbffr