Pilot Plant Quality Control Associate Expert

Novartis Italia; Ivrea; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A global pharmaceuticals company located in Ivrea is seeking a laboratory professional. The role involves executing analyses of pharmaceutical products, performing validations, and ensuring compliance with GMP standards. Candidates should have a degree in Chemistry and experience in the pharmaceutical industry. Fluency in Italian and English is required. Working collaboratively with different departments and participating in audits are integral to this position.

Competenze

• 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.

Mansioni

• Executes analyses on excipients, raw materials, finished products, and packaging.
• Conducts stability studies, process and method validations.
• Performs instrument qualification and re-qualification.
• Records analytical data in compliance with ALCOA+ principles.
• Reviews GMP documentation, batch records, and analytical reports.
• Collaborates with QA, Production, and R&D.
• Participates in audits and inspections.

Conoscenze

Chemistry laboratory skills

GMP knowledge

Data integrity compliance

Communication in Italian and English

Formazione

Degree in Chemistry

Descrizione del lavoro

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.

About the Role

Location: Ivrea, Italy (onsite)

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

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.

Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards