pSalary Range: €29,800.00
- €55,300.00 /ph3Job Description Summary /h3pLocation: Ivrea, Italy #onsite /ph3Role Purpose: /h3pDuring 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. /ppThe 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. /ppHiring 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 hand-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. /ph3Major Accountabilities /h3ulliAct 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. /liliReview 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. /liliEnsure that global applications,



locally configured systems, infrastructure components, equipment software, interfaces, and data flows are appropriately assessed, qualified, and released before GMP use. /liliEnsure clear definition of responsibilities among system owners, system users, IT, OT, Engineering, Quality, and support functions throughout the system lifecycle. /liliEnsure 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. /liliReview and approve changes, deviations, CAPAs, and risk assessments affecting GMP-relevant computerized systems. /liliCoordinate and support periodic reviews to confirm that computerized systems remain compliant, supported, secure, fit for intended use, and in a validated state. /liliSupport 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. /liliSupport internal audits and Health Authority inspections involving computerized systems, data integrity, automation, electronic records, and electronic signatures. /liliContribute 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 /ulh3Key Performance Indicators /h3ulliTimely qualification and release of GMP-relevant IT/OT and computerized systems in line with approved quality standards and project timelines. /liliTimely completion of validation deliverables, periodic reviews, deviations, CAPAs, changes, and access reviews. /liliPositive outcomes from internal audits and external inspections, with no critical compliance gaps attributable to QA oversight of IT/OT systems. /liliConsistent role-modeling of Novartis culture, values, and behaviours within the QA organization and cross-functional teams. /li /ulh3Work Experience /h3ulliComputerized-system validation and qualification /liliIT Quality and eCompliance /liliOperational Technology and industrial automation /liliPharmaceutical manufacturing and laboratory systems /liliData integrity, electronic records, and electronic signatures /liliIT infrastructure qualification /liliSystem lifecycle and periodic review management /liliChange, deviation, and CAPA management /liliSupplier and IT/OT service-provider oversight /liliAudit and Health Authority inspection support /liliQuality Management Systems /liliGxP documentation and procedure management /li /ulh3Prerequisites /h3ulliMinimum 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. /liliFamiliarity with applicable GxP and computerized-system compliance expectations, including EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and data-integrity guidance. /liliHands-on experien

📌 TRD QA Specialist (Ivrea)
🏢 Novartis
📍 Ivrea