Audit Specialist
LocationMonza, Italy
Work modehybrid
Typefull-time
SeniorityLead
Experience4+ yrs
DepartmentQuality
Company size10,000+ people
PostedOct 8, 2026 · 5d ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
4 years of experience in pharmaceutical quality assurance or related GMP environment
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
Knowledge of root cause analysis and quality improvement tools
Demonstrated ability to guide and develop team members
Ability to understand and interpret technical procedures and specifications
Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field
Experience with clean room operations and gowning procedures preferred
Ability to work various shifts as required
Skills
TrackWise
Documentum
Microsoft Office
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
About the company
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.
DESCRIPTION:
Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you’ll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.
Requirements
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
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