Description
1. Primary point of contact between Quality and Automation / IT departments / Global Technical functions
2. Support other departments including QC and Manufacturing to identify technical solutions that address data integrity requirements and provide guidance to final users
3. 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:
4. Participate in DI Quality Councils, CoP and local Steering Committee
5. Participate in Change Control assessment, including risk assessment process, as DI/IT/OT expert
6. Collaborate with Automation and IT departments to identify technical solutions that address data integrity requirements and provide guidance to final users
7. Support the site Digitalization and Automation projects, including Agile 4.0 initiatives and Quality Roadmap
8. Support Data Analysis and Data Management initiatives that allow agile management of quality KPI and data
9. Identify and propose new systems and digital solutions to increase process efficiency and support paperless goals
10. 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
11. 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
12. Very strong knowledge on ITIL framework and IT/OT compliance standard
13. Knowledge of cybersecurity measures would complete the role
14. Knowledge in data management, restore and recovery processes
15. Experiences in management and execution of IT processes in regulated environment
16. Technical degree preferred in Computer Engineering, IT or equivalent. Mandatory: Studies in Cybersecurity and Data Integrity
17. At least 5 years of experience in pharmaceutical IT QSY/IT/OT departments
18. Consolidated skills regarding the ITIL framework, infrastructure management.
19. Fluent in English and Italian
20. Preferred knowledge of Power Automate
Leadership
21. Demonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business
22. Focuses on the few priorities and delivers superior results
23. Elevates the capabilities of the organization for now and the future
24. Creates the environment that inspires and enables people to move the organization forward
Decision-making and Autonomy
25. Experience in Data Integrity
26. Experience in IT/OT environments
27. Problem solving attitude
28. Knowledge of GMP regulation
Interaction
29. Local and Global DD&T and Automation teams, Laboratory contractors and vendors, regulatory authority during audit and other technical functions
Innovation
30. 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
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Locations
ITA - Rieti
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time