Visual Inspection SME — AI-Enabled Quality Leader

Vantive; Castlebar; On-site; EUR 70,000 - 100,000; Full time

Job summary

Vantive in Ireland is seeking a Visual Inspection Subject Matter Expert to provide technical leadership and continuous improvement of VI processes for pharmaceutical products. The role ensures compliance with EU GMP Annex 1, FDA guidance, and USP , and includes advanced oversight of manual and automated inspection activities.

You will drive qualification programs, participate in audits, and partner with Production and QA to sustain inspection-ready practices and KPI reporting.

Qualifications

• Minimum 5 years' experience in pharmaceutical manufacturing or quality operations.
• Minimum 3 years' experience in Visual Inspection of sterile pharmaceutical products.
• Experience with GMP-regulated environments and regulatory inspections.

Responsibilities

• Maintain compliance of site Visual Inspection procedures with global regulatory requirements.
• Lead and implement changes to align VI processes with new regulatory guidance.
• Provide technical oversight of manual and automated visual inspection activities.
• Develop and report Knapp studies and other VI studies.
• Oversee operator qualification programs and CAPAs related to VI performance.
• Collaborate with cross-functional teams to standardize VI programs across sites.

Skills

Analytical thinking

Technical writing

Communication

Stakeholder influence

Project management

Detail oriented

Education

Bachelor's degree in science/engineering/pharma

Master's degree desirable

Job description

Vantive in Ireland is seeking a Visual Inspection Subject Matter Expert to provide technical leadership and continuous improvement of VI processes for pharmaceutical products. The role ensures compliance with EU GMP Annex 1, FDA guidance, and USP , and includes advanced oversight of manual and automated inspection activities.

You will drive qualification programs, participate in audits, and partner with Production and QA to sustain inspection-ready practices and KPI reporting.