Audit 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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

REQUIREMENTS:

• 4 years of experience in pharmaceutical quality assurance or related GMP environment
• Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field
• Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
• Expertise in batch record review, deviation investigations and CAPA management
• Strong understanding of aseptic manufacturing processes and controls
• Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)
• Professional communication skills both written and spoken
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Project management and organizational capabilities
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Ability to work various shifts as required
• Knowledge of root cause analysis and quality improvement tools
• Demonstrated ability to guide and develop team members
• Experience with clean room operations and gowning procedures preferred
• Ability to understand and interpret technical procedures and specifications

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.