QA Lead: GMP, CAPA & Regulatory Readiness

Experteer Italy; Monza; On-site; EUR 65,000 - 95,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Quality Assurance

CAPA Management

Deviation Investigations

Regulatory Inspections

Cross-functional Collaboration

Document Control

Root Cause Analysis

Analytical Thinking

Communication Skills

Tools

TrackWise

Documentum

MS Office

Job description

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.