TRD QA Specialist
Pubblicato il 17-10-2026 - Novartis Italia in Ivrea
h3Role Purpose /h3 pDuring the Pilot Plant ramp-up and operationalization, provide QA oversight and support for the establishment of a compliant quality system for GMP-relevant IT, OT, computerized, and automated systems. The role focuses on system qualification and validation, data integrity, lifecycle documentation, procedures, interfaces, equipment connectivity, and ongoing compliance. /p h3Summary /h3 pLocation: Ivrea, Italy #onsite /p h3Role Purpose /h3 pDuring the Pilot Plant ramp-up and operationalization, provide QA oversight and support for the establishment of a compliant quality system for GMP-relevant IT, OT, computerized, and automated systems. The role focuses on system qualification and validation, data integrity, lifecycle documentation, procedures, interfaces, equipment connectivity, and ongoing compliance. /p pThe QA Specialist will support the implementation and qualification of computerized systems used in manufacturing, QC laboratories, facilities, utilities, and supply-chain processes. In routine operations, the role ensures that these systems remain compliant, fit for intended use, and maintained in a validated state throughout their lifecycle. /p pHiring a QA Specialist with IT/OT expertise for the TRD RLT Colleretto Giacosa Pilot Plant is essential to establish local Quality capability for IT/OT system qualification, procedure development, and initial manufacturing-line validation. The role requires hands‑on experience with computerized systems in pharmaceutical or regulated environments, strong knowledge of quality assurance and data‑integrity principles, and effective collaboration with all the stakeholders. /p h3About The Role /h3 h3Major Accountabilities /h3 ul liAct as the local QA subject‑matter expert for GMP‑relevant IT/OT systems, providing independent quality oversight while supporting cross‑functional execution during project ramp‑up. /li liReview and approve key validation and qualification deliverables, including User Requirements Specifications, risk assessments, validation plans, test protocols, executed test evidence, deviations, and qualification or validation summary reports. /li liEnsure that global applications, locally configured systems, infrastructure components, equipment software, interfaces, and data flows are appropriately assessed, qualified, and released before GMP use. /li liEnsure clear definition of responsibilities among system owners, system users, IT, OT, Engineering, Quality, and support functions throughout the system lifecycle. /li liEnsure implementation and QA oversight of controls related to user access, audit trails, electronic records, electronic signatures, backup, restoration, archiving, business continuity, system security, and data integrity. /li liReview and approve changes,
deviations, CAPAs, and risk assessments affecting GMP‑relevant computerized systems. /li liCoordinate and support periodic reviews to confirm that computerized systems remain compliant, supported, secure, fit for intended use, and in a validated state. /li liSupport the drafting, review, approval, and maintenance of GxP procedures governing computerized‑system validation, system administration, access management, audit‑trail review, backup and restore, incident management, change control, periodic review, and system retirement. /li liSupport internal audits and Health Authority inspections involving computerized systems, data integrity, automation, electronic records, and electronic signatures. /li liContribute to continuous improvement initiatives, including optimization of validation activities and implementation of risk‑based quality practices aligned with the operational maturity of the Pilot Plant. /li /ul h3Key Performance Indicators /h3 ul liTimely qualification and release of GMP‑relevant IT/OT and computerized systems in line with approved quality standards and project timelines. /li liTimely completion of validation deliverables, periodic reviews, deviations, CAPAs, changes, and access reviews. /li liPositive outcomes from internal audits and external inspections, with no critical compliance gaps attributable to QA oversight of IT/OT systems. /li liConsistent role modelling of Novartis culture, values, and behaviours within the QA organization and cross‑functional teams. /li /ul h3Work Experience /h3 pDemonstrated experience across several of the following areas: /p ul liComputerized‑system validation and qualification /li liIT Quality and eCompliance /li liOperational Technology and industrial automation /li liPharmaceutical manufacturing and laboratory systems /li liData integrity, electronic records, and electronic signatures /li liIT infrastructure qualification /li liSystem lifecycle and periodic review management /li liChange, deviation, and CAPA management /li liSupplier and IT/OT service‑provider oversight /li liAudit and Health Authority inspection support /li liQuality Management Systems /li liGxP documentation and procedure management /li /ul h3Prerequisites /h3 ul liMinimum of three years of proven experience in the pharmaceutical or similarly regulated industry in Quality Assurance,
computerized‑system validation, laboratory computerized‑system support, manufacturing automation, IT/OT quality, or a comparable role. /li liFamiliarity with applicable GxP and computerized‑system compliance expectations, including EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and data‑integrity guidance. /li liHands‑on experience with IT, OT, computerized, automated, manufacturing, or laboratory systems used in a regulated environment. /li liSolid knowledge of computerized‑system lifecycle management, qualification, validation, Quality Systems, and data‑integrity principles. /li liExperience preparing, reviewing, executing, or approving computerized‑system qualification and validation documentation. /li liAbility to understand system architecture, interfaces, data flows, infrastructure dependencies, equipment connectivity, and electronic records. /li liExperience working with electronic Quality Systems for change controls, deviations, CAPAs, and related quality processes. /li liStrong quality mindset, ownership, analytical thinking, and ability to work effectively in cross‑functional teams. /li liProactive approach and continuous‑improvement mindset. /li /ul h3Languages /h3 ul liItalian /li liEnglish, intermediate level or above /li /ul h3Benefits Rewards /h3 pAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. /p h3Expected Annual Base Salary Range for role: €29,800 to € 55,300 /h3 pThe base salary offered is determined based on gender‑neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. /p pIn addition to your base salary, you may be eligible for a performance‑based premio depending on certain performance parameters. /p pThe rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. /p h3Why Novartis: /h3 pHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? /p h3Benefits and Rewards: /h3 pLearn about all the ways we’ll help you thrive personally and professionally. /p pRead our handbook (PDF 30 MB) /p #J-18808-Ljbffr