Thermo Fisher Scientific seeks an Audit Specialist to oversee product quality and regulatory compliance in pharmaceutical manufacturing. The role involves quality assurance oversight, batch record review, deviation investigation, and support for regulatory inspections to ensure adherence to GMP standards and FDA guidelines.
Responsibilities
Review batch records and conduct deviation investigations to ensure regulatory compliance
Manage corrective and preventive action processes to address quality issues
Support regulatory inspections and customer audits with documentation and coordination
Guide and mentor team members on quality procedures and best practices
Maintain quality documentation systems and interpret technical procedures
Requirements




4 years of experience in pharmaceutical quality assurance or GMP environment
Background in 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
Advanced proficiency in quality documentation systems such as TrackWise or Documentum
Understanding of aseptic manufacturing processes and clean room operations
Root cause analysis and quality improvement tools experience

📌 Audit Specialist (Monza)
🏢 Thermo Fisher Scientific
📍 Monza