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Pilot plant quality control associate expert

Ivrea
Novartis
Pubblicato il 8 gennaio
Descrizione

Job Description Summary

Location: Ivrea, Italy #onsite

Role Purpose:
This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.

Job Description


Key responsibilities:

* Executes analyses on excipients, raw materials, finished products, and packaging per internal SOPs and applicable pharmacopeias.

* Conducts stability studies, process and method validations, and activities related to tech transfer of pharmaceutical products.

* Performs instrument qualification and re-qualification (IQ/OQ/PQ) according to internal procedures.

* Records analytical data in compliance with ALCOA+ principles and data integrity requirements.

* Reviews GMP documentation, batch records, analytical reports, and certificates for completeness and compliance.

* Collaborates with QA, Production, and R&D; supports method transfers, troubleshooting, and safe lab/5S practices.

* Participates in audits and inspections by providing data and responses; contributes to CAPA, deviations, change control, and SOP updates.

* Tracks KPIs: on-time completion and right-first-time rates, data integrity compliance, audit outcomes, documentation quality, and continuous improvement impact.

Essential Requirements:

* Degree in Chemistry

* Solid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysis

* Previous experience working in a laboratory environment in the pharmaceutical industry

* Experience in GMP environment

* Fluent in Italian and English

Skills Desired

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