QA CAPA/ NCR Governance Engineer
On-siteCastlebar, Connacht, Ireland
Job Summary
QA NCR Governance Engineer responsible for overseeing Non-Conformance Reports (NCRs) and CAPA activities across the site, ensuring quality records are managed in line with site procedures and quality standards and that KPI targets and GMP/regulatory requirements are met. Responsibilities include tracking NCRs and CAPAs to closure, conducting monthly NCR and exception trending analysis, reporting site quality and QCR metrics, performing adequacy reviews, escalating quality issues to the CRB, hosting CRB meetings and CAPA update boards, serving as site SME for NCR/CAPA processes, delivering training on NCR/CAPA management, and supporting continuous improvement within the Quality Management System.
Required 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.
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