IT Quality System Expert
2 settimane fa
Job Description 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 Champion 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 Ensure compliance with applicable regulations requirements regarding data integrity Locations ITA - Rieti Worker Type Employee Worker Sub-Type Regular Time Type Full time #J-18808-Ljbffr
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