Lead QA Visual Inspection & Compliance (GMP)

Vantive; Castlebar Municipal District (2014-2019); On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Private Medical Insurance

Life Assurance

Annual Bonus Scheme

Pension Contribution

Job summary

Vantive, a vital organ therapy company focused on extending lives through digital solutions in kidney care, seeks a Visual Inspection Subject Matter Expert (SME). The role provides technical leadership, oversees manual and automated visual inspection for pharmaceutical products, and ensures compliance with global regulations and emerging technologies like AI-assisted inspection systems.

The SME will lead the site in maintaining inspection readiness, oversee qualification programs, and drive

Qualifications

• 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 environments, regulatory inspections and audits.

Responsibilities

• Maintain and ensure ongoing 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 standards.
• Represent the site at 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 remain inspection-ready and GMP-compliant.
• Oversee qualification and requalification programs for Visual Inspection operators.
• Develop, execute, and report on visual inspection studies and analyses.
• Provide technical conclusions from study outcomes and drive improvements.

Skills

5+ years pharma manufacturing

3+ years visual inspection of sterile

Knapp studies

Operator qualification programs

GMP compliance

Regulatory inspections & audits

Education

Bachelor’s Degree in Science/related discipline

Master’s Degree desirable

Job description

Vantive, a vital organ therapy company focused on extending lives through digital solutions in kidney care, seeks a Visual Inspection Subject Matter Expert (SME). The role provides technical leadership, oversees manual and automated visual inspection for pharmaceutical products, and ensures compliance with global regulations and emerging technologies like AI-assisted inspection systems.

The SME will lead the site in maintaining inspection readiness, oversee qualification programs, and drive