Pds Quality On The Floor
Thermo Fisher Scientific seeks a Lead QA Technician for pharmaceutical manufacturing quality oversight in Monza, Italy. The role involves batch record review, deviation investigations, regulatory compliance, and aseptic process oversight on rotating shifts in a GMP cleanroom environment.
Responsibilities
Review batch records and investigate deviations to ensure regulatory compliance
Manage CAPA processes and support root cause analysis activities
Oversee aseptic manufacturing processes and quality controls
Support regulatory inspections and customer audits
Guide and develop team members on quality procedures
Requirements
4+ years pharmaceutical quality assurance or GMP environment experience
Chemistry, Pharmacy, Biology, Biotechnology, or related scientific degree
Comprehensive GMP regulations, FDA guidelines, and quality systems knowledge
Expertise in batch record review, deviation investigations, CAPA management
Advanced proficiency in quality documentation systems (TrackWise, Documentum)
Knowledge of root cause analysis and quality improvement tools
Clean room operations and gowning procedures experience preferred
Responsibilities
Review batch records and investigate deviations to ensure regulatory compliance
Manage CAPA processes and support root cause analysis activities
Oversee aseptic manufacturing processes and quality controls
Support regulatory inspections and customer audits
Guide and develop team members on quality procedures
Requirements
4+ years pharmaceutical quality assurance or GMP environment experience
Chemistry, Pharmacy, Biology, Biotechnology, or related scientific degree
Comprehensive GMP regulations, FDA guidelines, and quality systems knowledge
Expertise in batch record review, deviation investigations, CAPA management
Advanced proficiency in quality documentation systems (TrackWise, Documentum)
Knowledge of root cause analysis and quality improvement tools
Clean room operations and gowning procedures experience preferred