Audit Specialist (Monza)

Audit Specialist (Monza)

14 ott
|
Experteer Italy
|
Monza

14 ott

Experteer Italy

Monza

As Lead QA Technician, you ensure product quality and regulatory compliance within pharmaceutical manufacturing.
You will work as part of the Quality team to uphold high standards and support life-changing medicines.
Expect to investigate deviations, manage CAPA, and help prepare for regulatory inspections in an aseptic environment.
You will collaborate with cross-functional teams to maintain compliant documentation and processes, contributing to the mission of making the world healthier, cleaner and safer.
This role offers the chance to shape quality programs in a global, fast-paced setting.
La preghiamo di verificare di possedere il livello di esperienza e le qualifiche adeguate leggendo la panoramica completa di questa occasione qui sotto.
Quality oversight of pharmaceutical manufacturing operations
Batch record review and deviation investigations
CAPA management and effectiveness verification
Support regulatory inspections and customer audits
Maintain and improve quality systems and documentation (TrackWise, Documentum)
Collaborate with cross-functional teams to address quality issues
Ensure aseptic manufacturing processes and clean room controls
Communicate findings clearly and drive corrective actions
Guide and develop team members on quality practices




Manage multiple priorities in a dynamic environment
4 years of experience in pharmaceutical quality assurance or related GMP environment
Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
Experience with 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 (written and spoken)
Ability to manage multiple priorities and work under pressure
Strong attention to detail and analytical problem-solving skills
Interpersonal and xysqume communication abilities; project management and organizational capabilities
Experience supporting regulatory inspections and customer audits
Cross-functional team collaboration
Proficiency with Microsoft Office applications
Knowledge of root cause analysis and quality improvement tools
Experience with clean room operations and gowning procedures preferred
Ability to interpret technical procedures and specifications
As Lead QA Technician, you ensure product quality and regulatory compliance within pharmaceutical manufacturing.
You will work as part of th...
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📌 Audit Specialist (Monza)
🏢 Experteer Italy
📍 Monza

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