Quality Assurance Visual Inspection SME

About the company

At Vantive we are seeking an experience QA Visual Inspection Subject Matter Expert (SME) to join the team in Castlebar, Ireland.

Your tasks

You will be responsible for providing technical leadership, oversight, and continuous improvement of manual and automated visual inspection processes for pharmaceutical products. The role ensures compliance with regulatory requirements, global standards, internal procedures and emerging technologies such as Artificial Intelligence (AI)-assisted inspection systems.

• Maintain and ensure ongoing compliance of site Visual Inspection procedures with current global requirements, regulatory expectations, and industry best practices.
• Review and implement changes necessary to align Visual Inspection processes with new regulatory guidance and corporate standards.
• Represent the site at monthly Global Visual Inspection Council meetings and communicate key updates to stakeholders.
• Provide technical oversight of all manual and automated visual inspection activities.
• Ensure Visual Inspection processes remain inspection-ready and compliant with GMP requirements.
• Oversee qualification and requalification programs for Visual Inspection operators.
• Develop, execute, and report on Knapp studies and additional Visual Inspection studies.
• Provide scientific justification and technical conclusions arising from study outcomes.
• Challenge existing Visual Inspection practices and drive continuous improvement initiatives.
• Identify opportunities to improve defect detection capability, consistency, efficiency, and operator performance.
• Oversee corrective and preventive actions (CAPAs) related to Visual Inspection performance.
• Assess and implement industry best practices and technological advancements.
• Establish and maintain Visual Inspection Key Performance Indicators (KPIs).
• Work closely with Production and In-Process QA to ensure Visual Inspection sample packs and defect kits are maintained, representative, and compliant.
• Where applicable, participate in non-conformance investigations, root cause analysis, and quality risk assessments related to Visual Inspection.
• Provide technical expertise during process validation and qualification activities.

Requirements

Education

• Bachelor's Degree in Science, Pharmacy, Engineering, Biotechnology, Microbiology, Pharmaceutical Technology, or related discipline.
• Master's Degree desirable.

• Minimum 5 years' experience within pharmaceutical manufacturing or quality operations.
• Minimum 3 years' experience in Visual Inspection of sterile pharmaceutical products.
• Proven experience with:
• Manual Visual Inspection
• Knapp studies
• Operator qualification programs
• GMP-regulated manufacturing environments
• Regulatory inspections and audits

What we offer

• Private Medical Insurance
• Life Assurance
• Annual Bonus Scheme
• Pension Contribution