Audit Specialist

Experteer Italy; Monza; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Experteer Italy is seeking a Lead QA Technician to ensure product quality and regulatory compliance in pharmaceutical manufacturing. You will investigate deviations, manage CAPA, and support regulatory inspections in an aseptic environment while collaborating with cross-functional teams to maintain compliant documentation.

You will contribute to shaping quality programs in a global, fast-paced setting and guide team members on best quality practices across TrackWise and Documentum platforms.

Qualifications

• 4 years of experience in pharmaceutical quality assurance or 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.

Responsabilités

• 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.

Connaissances

Quality Assurance

CAPA Management

Deviation Investigations

Regulatory Inspections

Cross-functional Collaboration

Document Control

Root Cause Analysis

Analytical Thinking

Communication Skills

Outils

TrackWise

Documentum

MS Office

Description du poste

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.

• 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 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…