QA CAPA/ NCR Governance Engineer

Vantive; Ireland; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Competitive salary and annual bonus opportunity

Pension scheme

Health and wellbeing programmes

Employee Assistance Programme (EAP)

Life assurance and income protection

Generous annual leave entitlement

Flexible working arrangements

Learning and development opportunities

Internal career progression

Recognition and reward programmes

Inclusive and collaborative working environment

Job summary

Vantive is seeking a QA NCR Governance Engineer in Ireland. This role involves oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities, ensuring compliance with GMP and managing quality records. Ideal candidates will have experience within the pharmaceutical, biotechnology, or regulated manufacturing sectors.

The position offers a competitive salary, annual bonus opportunity, and a range of benefits including pension scheme, health programmes, and flexible working arrangements.

Qualifications

• Experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Experience in a Quality Assurance or Quality Systems role.
• Strong communication, organisational, and stakeholder management skills.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.

Responsibilities

• Complete NCR and CAPA records in line with site procedures.
• Track NCRs and CAPAs to closure.
• Conduct monthly NCR and exception trending analysis.
• Track and report site Quality and QCR metrics.
• Perform adequacy reviews of NCR and CAPA records.
• Escalate quality issues to the Corrective Review Board.
• Host CRB meetings and weekly CAPA update boards.
• Deliver training and guidance on NCR and CAPA management.
• Support continuous improvement initiatives.

Skills

Strong communication skills

Organisational skills

Stakeholder management

Technical writing

Analytical abilities

Problem-solving abilities

Education

Experience in Quality Assurance or Quality Systems

Experience in pharmaceutical or regulated manufacturing

Job description

QA NCR Governance Engineer

The QA NCR Governance Engineer is responsible for the oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities across the site. The role ensures quality records are effectively managed, KPI targets are achieved, and compliance with GMP and regulatory requirements is maintained.

Key Responsibilities

• Complete NCR and CAPA records in line with site procedures and quality standards.
• Track NCRs and CAPAs to closure, ensuring timelines and KPI targets are met.
• Conduct monthly NCR and exception trending analysis and communicate findings.
• Track and report site Quality and QCR metrics.
• Perform adequacy reviews of NCR and CAPA records.
• Escalate quality issues to the Corrective Review Board (CRB) as required.
• Host CRB meetings and weekly CAPA update boards.
• Serve as the site subject matter expert and point of contact for NCR and CAPA processes.
• Deliver training and guidance on NCR and CAPA management.
• Support continuous improvement initiatives within the Quality Management System.

Qualifications & Experience

Experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.

• Experience in a Quality Assurance or Quality Systems role.
• Strong communication, organisational, and stakeholder management skills.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.

Benefits at Vantive

• Competitive salary and annual bonus opportunity
• Pension scheme
• Health and wellbeing programmes
• Employee Assistance Programme (EAP)
• Life assurance and income protection
• Generous annual leave entitlement
• Flexible working arrangements (role dependent)
• Learning and development opportunities
• Internal career progression and global mobility opportunities
• Recognition and reward programmes
• Inclusive and collaborative working environment

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 let us know the nature of your request along with your contact information. Form Link