QA Visual Inspection SME

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 is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Visual Inspection Subject Matter Expert (SME)

The Visual Inspection 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.

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

Benefits

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

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link