Senior Visual Inspection QA Lead – Pharma (GMP)

Vantive; Castlebar; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Private Medical Insurance

Life Assurance

Annual Bonus Scheme

Pension Contribution

Job summary

Vantive is seeking a Visual Inspection Subject Matter Expert to lead and continuously improve manual and automated visual inspection processes for pharmaceutical products, ensuring compliance with GMP, regulatory requirements and evolving standards.

You will oversee qualification programs, Knapp studies, CAPAs, and KPI reporting, collaborate with Production and QA, participate in audits, and drive enhancements in defect detection, efficiency, and process robustness.

Qualifications

• Bachelor's degree is required in science-related discipline.
• Master's degree is desirable.
• Minimum 5 years in pharmaceutical manufacturing or quality operations.
• Minimum 3 years in visual inspection of sterile pharmaceutical products.
• Experience with Manual Visual Inspection, Knapp studies, operator qualification programs, GMP environments, regulatory inspections.

Responsibilities

• Maintain compliance of Visual Inspection procedures with global requirements and regulatory expectations.
• Review and implement changes to align Visual Inspection processes with new regulatory guidance and corporate standards.
• Represent the site at monthly Global Visual Inspection Council meetings and communicate updates to stakeholders.
• Provide technical oversight of all manual and automated visual inspection activities.
• Ensure Visual Inspection processes are inspection-ready and GMP-compliant.
• Oversee qualification and requalification programs for Visual Inspection operators.
• Develop, execute, and report on Knapp studies and other Visual Inspection studies.
• Provide scientific justification and technical conclusions from study outcomes.
• Drive continuous improvement initiatives and identify opportunities to improve defect detection, consistency, efficiency.

Skills

Visual inspection

GMP compliance

Education

Bachelor's degree in Science, Pharmacy, Engineering

Master's degree desirable

Tools

Knapp studies

Operator qualification programs

Job description

Vantive is seeking a Visual Inspection Subject Matter Expert to lead and continuously improve manual and automated visual inspection processes for pharmaceutical products, ensuring compliance with GMP, regulatory requirements and evolving standards.

You will oversee qualification programs, Knapp studies, CAPAs, and KPI reporting, collaborate with Production and QA, participate in audits, and drive enhancements in defect detection, efficiency, and process robustness.