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 h

📌 TRD QA Specialist (Ivrea)
🏢 Novartis Italia
📍 Ivrea