TRD QA Specialist at Novartis

Ivrea, Piedmont, Italy -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

0.0

Posted On

02 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Management Systems, Aseptic Processing, Deviation Management, Change Control Management, SOP Management, Manufacturing Oversight, Collaboration, Communication Skills, Problem Solving, Risk Management, Leadership, Data Integrity, Regulatory Requirements, Continuous Improvement, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

Job Description 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. Job Description 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. Skills Desired Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge, Risk Management, Stakeholder Management Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The TRD QA Specialist will support the pilot plant ramp-up and operationalization by developing and maintaining a compliant manufacturing and QC quality system. They will oversee initial validation activities and coordinate the QA shopfloor team, ensuring compliance and quality oversight during manufacturing and QC operations.