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Previa 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.
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
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