TRD QA Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cu2td

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 experience with IT, OT, computerized, automated, manufacturing, or laboratory systems used in a regulated environment. /liliSolid knowledge of computerized-system lifecycle management, qualification, validation, Quality Systems, and data-integrity principles. /liliExperience preparing, reviewing, executing, or approving computerized-system qualification and validation documentation. /liliAbility to understand system architecture, interfaces, data flows, infrastructure dependencies, equipment connectivity, and electronic records. /liliExperience working with electronic Quality Systems for change controls, deviations, CAPAs, and related quality processes. /liliStrong quality mindset, ownership, analytical thinking, and ability to work effectively in cross-functional teams. /liliProactive approach and continuous-improvement mindset. /li /ulh3Languages /h3ulliItalian /liliEnglish, intermediate level or above /li /ulh3Benefits Rewards /h3pAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. /ppExpected Annual Base Salary Range for role: €29,800 to € 55,300 /ppThe 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. /ppIn addition to your base salary, you may be eligible for a performance-based premio depending on certain performance parameters. /ppThe 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 #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cu2td