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

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Locations: ITA - Rieti
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time

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