Pharma GMP QA Auditor & CAPA Specialist

ThermoFisher Scientific; Monza; On-site; EUR 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific in Monza, Lombardy seeks an experienced Quality Assurance professional to join its GMP-focused team. You will contribute to batch record reviews, deviations, and CAPA activities to ensure product quality and regulatory compliance.

This role requires collaboration with cross-functional groups in a fast-paced environment, strong analytical skills, and excellent communication. The ideal candidate will have 4+ years in QA, knowledge of aseptic processes, and proficiency with

Qualifications

• Minimum 4 years of experience in pharmaceutical quality assurance or GMP environment.
• Preferred: Chemistry, Pharmacy, Biology, Biotechnology or related field.
• Strong knowledge of GMP regulations, FDA guidelines and quality systems.
• Experience with batch record review, deviation investigations and CAPA management.
• Understanding of aseptic manufacturing processes and controls.
• Proficiency with quality documentation systems (TrackWise, Documentum).
• Excellent written and spoken communication.
• Ability to manage multiple priorities in a dynamic environment.
• Attention to detail and analytical problem-solving.
• Experience supporting regulatory inspections and customer audits.
• Experience working with cross-functional teams.
• Proficient with Microsoft Office.
• Ability to work various shifts as required.
• Knowledge of root cause analysis and quality improvement tools.
• Experience with clean room operations and gowning procedures preferred.
• Ability to understand and interpret technical procedures and specifications.

Skills

Quality assurance

CAPA management

Root cause analysis

Regulatory inspections support

Cross-functional teamwork

Project management

Analytical thinking

Communication skills

Education

Bachelor's in Chemistry/Pharmacy/Biology/Biotechnology

Tools

TrackWise

Documentum

Job description

Thermo Fisher Scientific in Monza, Lombardy seeks an experienced Quality Assurance professional to join its GMP-focused team. You will contribute to batch record reviews, deviations, and CAPA activities to ensure product quality and regulatory compliance.

This role requires collaboration with cross-functional groups in a fast-paced environment, strong analytical skills, and excellent communication. The ideal candidate will have 4+ years in QA, knowledge of aseptic processes, and proficiency with