It Quality System Expert

Selecta sas; Lazio; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Una società farmaceutica è alla ricerca di un esperto in sistemi informatici con forte affinità per le tecnologie e oltre 5 anni di esperienza in IT/OT. I candidati ideali dovrebbero possedere competenze in Cybersecurity, conoscenze del framework ITIL e flessibilità nell'interazione locale e globale. Offriamo un contratto a tempo pieno in un ambiente innovativo con sede a Rieti.

Competenze

• Minimo 5 anni di esperienza in reparti IT farmacologici.
• Consolidate competenze riguardo il framework ITIL.
• Fluente in Inglese e Italiano.

Mansioni

• Fornire supervisione delle attività di sistema informatico GxP.
• Collaborare con i dipartimenti di Automazione e IT per identificare soluzioni tecniche.
• Promuovere l'innovazione digitale in processi regolamentati.

Conoscenze

Affinità ai sistemi informatici

Conoscenza del framework ITIL

Conoscenza della gestione dei dati

Problem solving

Competenze in Cybersecurity

Competenze di leadership

Interazione locale e globale

Formazione

Laurea tecnica in Informatica, IT o equivalente

Studi in Cybersecurity e Integrità dei Dati

Strumenti

Power Automate

Descrizione del lavoro

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