TRD QA Specialist

Major Accountabilities:

• Support the pilot plant ramp‑up and operationalization by contributing to the development, implementation, and maintenance of a compliant manufacturing and QC quality system, with particular focus on master batch records, logbooks, forms, and GMP procedures.
• Oversee and support initial manufacturing and QC validation activities, including water runs, engineering batches, APSs, and QC laboratory instrument Performance Qualifications (PQs), ensuring documentation completeness and GMP compliance.
• In routine operations, coordinate and provide leadership to the QA shopfloor team, ensuring continuous QA presence during manufacturing and QC activities.
• Perform real‑time manufacturing and QC oversight, including review and approval of deviations, OOX/OOS events, and execution of immediate quality decisions on the shopfloor.
• Review, approve, and ensure completeness and accuracy of batch manufacturing records, supporting the Qualified Person (QP) in the timely release of Phase I/II clinical trial radiopharmaceutical products.
• Ensure timely collection, monitoring, and reporting of Quality KPIs, supporting management reporting and continuous performance monitoring of manufacturing and QC activities.
• Actively support Health Authority inspections and internal audits, ensuring timely provision of accurate documentation, data, and subject‑matter expertise, and contributing to inspection readiness activities.
• Manage and oversee GxP Quality System processes, including Change Control, Deviation Management and CAPA, ensuring full compliance with GxP requirements and the Novartis Quality Manual.
• Ensure effective tracking, escalation, and timely closure of CAPAs, including proactive management of risks related to delayed or ineffective actions.
• Prepare, review, approve, and manage GxP documentation lifecycle activities, including document issuance, filing, archiving, and controlled distribution.
• Actively contribute to continuous improvement initiatives, including optimization of existing processes and implementation of enhanced quality practices aligned with operational maturity of the pilot plant.

Key Performance Indicators:

• Successful support of projects and routine operations in line with agreed quality standards and delivery timelines.
• Positive outcomes of internal and external inspections, with no critical compliance gaps attributable to QA oversight.
• Demonstrated ability to maintain effective collaboration and sound working relationships with manufacturing, QC, technical operations, and QA teams.
• Consistent role modeling of Novartis culture, values, and behaviors within the QA organization and cross‑functional teams.

Work Experience:

• Quality Assurance in pharmaceutical sterile manufacturing environments
• Audit and Health Authority Inspection Management
• Quality Management Systems (QMS)
• Sterile Manufacturing Operations (DP or API)
• Aseptic Processing and Contamination Control
• Deviation, Incident, and Escalation Management
• OOX/OOS and Investigation Management
• Corrective and Preventive Actions (CAPA)
• Change Control Management
• SOP and Documentation Management
• Manufacturing and QC Oversight

Prerequisites:

• Proven experience of minimum 3 years working on the shopfloor of a sterile pharmaceutical manufacturing site (Drug Product or API).
• Solid and demonstrable knowledge of Quality Systems, Data Integrity principles, and aseptic processing.
• Experience working with electronic quality systems (e.g. change controls, deviations, OOX, complaints, etc.)
• Strong quality mindset, leadership and cross‑functional attitude
• Proactive and continuous improvement mindset

Languages:

• Italian
• English (intermediate level)

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.