Visual Inspection Expert

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

We are seeking a Visual Inspection Subject Matter Expert (SME) to join our team in Castlebar!

Position Summary

The Visual Inspection (VI) Subject Matter Expert (SME) is 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.

Key Responsibilities

• 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.
• Defend Visual Inspection programs, studies, and qualification approaches during inspections and audits.
• Ensure all Visual Inspection records and documentation remain audit-ready at all times.
• Support the Vantive Global Visual Inspection Team by providing site-specific expertise and input.
• Participate in global harmonization initiatives and best-practice sharing.
• Collaborate with cross-functional and global teams to standardize Visual Inspection programs where appropriate.
• Evaluate and implement future improvements to Visual Inspection programs.

Required Qualifications

Education

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

Experience

• 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

Technical Knowledge

• Strong understanding of:
• EU GMP Annex 1
• FDA Guidance and Expectations for Visual Inspection
• USP <790> Visible Particulates

Competencies

• Strong analytical and problem-solving abilities.
• Excellent technical writing and report generation skills.
• Effective communication and presentation skills.
• Ability to influence stakeholders across multiple functions.
• Strong attention to detail and quality focus.
• Capacity to manage multiple projects simultaneously.
• Leadership and mentoring capability.

Success Measures

• Sustained compliance of the Visual Inspection program.
• Improvement in defect detection performance.
• Successful execution of Knapp studies and validation activities.
• Effective implementation of AI and future inspection technologies.
• Positive outcomes from regulatory inspections.
• Continuous improvement and standardization of site Visual Inspection processes.