TRD QA Specialist
Experteer Italy
Experteer Overview
In this role you will support the pilot plant ramp-up and establish a compliant manufacturing and QC quality system. You will oversee initial validation activities and QC PQs while coordinating the QA shopfloor team to ensure GMP compliance and timely batch release with the QP for Phase I/II radiopharmaceuticals. You will drive real-time QA oversight, CAPA, change control, and document lifecycle management, contributing to inspection readiness and continuous improvement. The position offers a meaningful impact on patient safety and manufacturing quality at a global pharma leader.Retribuzione / Benefits
- Support pilot plant ramp-up and implement a compliant manufacturing and QC quality system focusing on master batch records, logbooks, forms, and GMP procedures
- Oversee initial manufacturing and QC validation activities (water runs, engineering batches, APSs) and QC instrument PQs ensuring GMP compliance
- Coordinate and lead the QA shopfloor team to maintain continuous QA presence during manufacturing and QC activities
- Perform real-time oversight including review/approval of deviations, OOX/OOS events, and immediate quality decision‑making on the shop floor
- Review and approve batch manufacturing records; support QP for timely release of Phase I/II radiopharmaceutical products
- Monitor and report Quality KPIs to support management decisions and continuous performance improvement
- Support Health Authority inspections and internal audits with documentation readiness and subject‑matter expertise
- Manage GxP quality system processes (Change Control, Deviation Management, CAPA) ensuring full compliance with Novartis Quality Manual
- Prepare, review, approve, and control GxP documentation lifecycle (issuance, filing, archiving, distribution)
- Contribute to continuous improvement initiatives aligned with pilot plant operational maturity
- Minimum 3 years on the shopfloor of a sterile pharmaceutical manufacturing site (Drug Product or API)
- Solid knowledge of Quality Systems, Data Integrity, and aseptic processing
- Experience with electronic quality systems (change controls, deviations, OOX, complaints)
- Strong quality mindset with leadership and cross‑functional attitude
- Proactive and continuous improvement mindset
Offerta di lavoro pubblicata 7 giorni fa
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