BRR & Disposition Quality Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b9zn6

Experteer Overview In this role you will ensure product quality and regulatory compliance to support production of life-changing medicines. You will join a quality-focused team that helps enable Thermo Fisher's mission to make the world healthier, cleaner and safer. You'll oversee quality activities across pharmaceutical manufacturing, solving complex problems and supporting inspections. This role offers collaboration with cross-functional teams and opportunities to drive improvements in aseptic processes and quality systems.
Retribuzione / Benefits Oversee quality oversight of pharmaceutical manufacturing operations
Review batch records and lead deviation investigations
Manage CAPA processes and track corrective actions
Support regulatory inspections and customer audits
Ensure compliance with GMP and FDA guidelines across quality documentation systems
Coordinate with cross-functional teams to drive quality improvements
Maintain knowledge of aseptic manufacturing controls and gowning procedures
Utilize quality systems (e.g., TrackWise, Documentum)



and MS Office for documentation and reporting
Responsabilità 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 (TrackWise, Documentum)
Professional communication skills (written and spoken)
Ability to manage multiple priorities in a dynamic environment
Strong attention to detail and analytical problem-solving
Effective interpersonal and communication abilities
Project management and organizational capabilities
Experience supporting regulatory inspections and customer audits
Experience working with cross-functional teams
Proficiency with Microsoft Office applications
Knowledge of root cause analysis and quality im

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b9zn6