IT Quality System Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7i0lui

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 **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 GMSGQ LI-LA1 **Locations**: ITA - Rieti **Worker Type**: Employee **Worker Sub-Type**: Regular **Time Type**: Tempo pieno

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7i0lui