Automation Data Integrity Expert

3 giorni fa

Santa Rufina, Italia Takeda Pharmaceutical A tempo pieno

**POSITION**:Automation Data Integrity Expert**:
**LOCATION**: RIETI, ITALY**:
**ABOUT THE ROLE**:

- ** Primary point of contact between Automation and Quality departments, in order to maximize the efficiency of the Automation Team in the managing and execution of all the activities Data Integrity relevant (DI Risk Assessment, Periodic Review, Audit Trail Review, Profiles Review,)**:

- ** Support other departments to develop, implement and support technical solutions that address data integrity requirements and provide guidance to final users.**:

- ** Ensuring reliability and efficiency of computerized systems supporting manufacturing operations and full adherence of plant computerized system to EU Annex 11 and CFR21 part 11 requirements.**:

- ** For the projects assigned, provide managerial direction and technical leadership for the design and development, with particular focus on data integrity matter, of automation and control systems in charge of, including engineering, startup, commissioning, and support to qualification.**:

- ** Adopting state of art technology in the development of computerized system.**:

- ** Harmonizing global standards in the design, qualification, and management of plant computerized systems, concerning the projects assigned.**:

- ** Providing support for end users through life-cycle document reviews, training, and hand over system to operations.**:

- ** Propose and develop new systems and digital solutions to increase process efficiency and support paperless goals**:
**WHAT YOU BRING TO TAKEDA**:

- **Bachelor’s degree is required in electronic/electrical Engineering or relevant engineering field.**:

- ** Multiyear experience as Computer system validation expert/lead in pharmaceutical or consultancy companies.**:

- ** Experience in pharmaceutical/biotech operations, with working knowledge of cGMPs, FDA regulatory guidelines and validation principles are required.**:

- ** Leadership, organizational planning, and project management skills, in additional to technical knowledge, is required to interact with multidisciplinary teams.**:

- ** Fluent in English language.**:

- ** National and international business trip availability.**:

- ** Strong self-accountability and result orientation.**:
**More about us**:
**At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.**:
**Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.**:
**Empowering our people to shine**:
**Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion,**_ sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._**:
**Locations**:
ITA - Rieti

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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