Salario: €50.000 – €70.000 per anno
Job DescriptionPrevia 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 environmentEDUCATION, 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-LA1Locations: ITA - RietiWorker Type: EmployeeWorker Sub-Type: RegularTime Type: Tempo pieno#J-18808-Ljbffr