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TRD QA Specialist

Novartis -
Ivrea, Piemonte

Candidati adesso

Dettagli della posizione

Tempo pieno

Qualifiche

Inglese
Controllo qualità
API
Produzione
Italiano

Descrizione completa della posizione

Summary

Location: Ivrea, Italy #onsite

Role Purpose:
During the pilot plant ramp up and operationalization support line units efforts in developing compliant manufacturing and QC-related quality system, with particular focus on master batch records, logbooks, forms, procedures. Oversee the manufacturing lines initial validation activities (e.g. water runs, engineering batches and eventually APSs) and QC laboratory instruments PQs.

In routine will be responsible to coordinate the QA shopfloor team and perform manufacturing and QC oversight, deviation and OOX review/approval, batch record review and support QP for the release of phase I/II clinical products.

About the Role

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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Development

Business Unit

Quality

Location

Italy

Site

Ivrea

Company / Legal Entity

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

Candidati adesso

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