TRD Sr. QA Specialist
Experteer Italy
Experteer Overview
In this role you will support the ramp up and operationalization of a pilot plant by building and maintaining compliant manufacturing and QC quality systems. You will work to ensure adherence to the Novartis Quality Manual, GxP, and regulatory requirements, including audits and inspections. The role involves managing documentation, CAPA follow-up, change controls, and KPI/KQI monitoring to sustain site compliance. You will liaise with cross‑functional teams to drive quality improvements and ensure timely, compliant project delivery. This position offers the chance to influence quality systems in a validated manufacturing environment.Benefits
- Support site qualification and validation activities (advising, review, approval)
- Implement and manage Quality Systems, including documentation control
- Oversee supplier management (agreements, oversight, audits)
- Coordinate CAPA activities and follow‑up
- Prepare and support audits and inspections, maintain certificates
- Review and approve change controls
- Oversee local DI and eCompliance activities (training, inspections, risk ID)
- Trend KPI/KQI data for quality performance
- Handle technical complaints, deviations, and quality events related to products, systems, or processes
- Minimum of 5 years in pharmaceutical industry (sterile preferred)
- Experience in regulatory HA inspection support (backroom/SME)
- Proven track record with QMS documentation management
- Fluency in English; Italian language listed as required
- Experience with electronic quality systems (change controls, deviations, OOX, complaints)
- Strong quality mindset, documentation, communication, and cross‑functional collaboration skills
Offerta di lavoro pubblicata 2 giorni fa
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