TRD QA Specialist

Job Description Summary

Job Description

Major Accountabilities:

• Support the pilot plant rampup 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 realtime 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 subjectmatter 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 crossfunctional 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 crossfunctional 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.

Skills Desired