QA Visual Inspection SME (Pharmaceutical Manufacturing)

Location: Castlebar, Mayo, Ireland

Company

Vital organ therapy company developing kidney care solutions, digital services, and advanced therapies to improve outcomes for patients and care teams.

What you will do

• Provide technical leadership and oversight for manual and automated visual inspection processes for pharmaceutical products.
• Maintain compliance with global requirements, regulatory expectations, internal procedures, and GMP standards.
• Develop, execute, and report on Knapp studies and other visual inspection studies, including scientific justification of conclusions.
• Oversee operator qualification and requalification programs, sample packs, defect kits, and visual inspection KPIs.
• Drive continuous improvement in defect detection, consistency, efficiency, and operator performance, including the assessment of AI-assisted inspection technologies.
• Support CAPAs, non-conformance investigations, root cause analysis, quality risk assessments, process validation, and qualification activities.

Requirements

• Bachelor's degree in science, pharmacy, engineering, biotechnology, microbiology, pharmaceutical technology, or a related discipline.
• At least 5 years of experience in pharmaceutical manufacturing or quality operations.
• At least 3 years of experience in visual inspection of sterile pharmaceutical products.
• Experience with manual visual inspection, Knapp studies, operator qualification programs, and GMP-regulated manufacturing.
• Experience with regulatory inspections and audits.
• Master's degree is desirable.

Culture & Benefits

• Private medical insurance.
• Life assurance.
• Annual bonus scheme.
• Pension contribution.
• Reasonable accommodations are available during the application and interview process.