Manufacturing Process RCA & CAPA Lead

ThermoFisher Scientific; Monza; In loco; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Manufacturing Process Expert to join our Monza site, where you will serve as an advanced root cause analysis expert within a cross-functional team focused on problem-solving and continuous improvement. You will drive quality excellence and support CAPA, deviations, and audits in a GMP environment.

The role requires strong analytical skills, English/Italian fluency, and experience with TrackWise and regulatory processes.

Competenze

• Degree in Chemistry/CTF/Biological Sciences or similar field.
• Experience in QA operations, deviation management, GMP manufacturing.
• Knowledge of GMP and national/international regulations.
• Fluency in English and Italian.

Mansioni

• Investigations: lead deviation management and cross-functional collaboration.
• Define investigation plans and guide Root Cause Analysis for deviations.
• Coordinate CAPA with cross-functional teams and support audits.
• Apply technical analysis to identify manufacturing issues and drive improvements.
• Share lessons learned during Technical Unit huddles and maintain KPI alignment.

Conoscenze

Root Cause Analysis

cGMP

TrackWise

CAPA

Deviations

Quality Assurance

Documentation

Regulatory Audit

Bilingual EN/IT

Formazione

Chemistry/CTF/Bio Sci degree

Strumenti

TrackWise

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Manufacturing Process Expert to join our Monza site, where you will serve as an advanced root cause analysis expert within a cross-functional team focused on problem-solving and continuous improvement. You will drive quality excellence and support CAPA, deviations, and audits in a GMP environment.

The role requires strong analytical skills, English/Italian fluency, and experience with TrackWise and regulatory processes.