QA Specialist

CAI is seeking an experienced QA Specialist to support a leading biotechnology client in Dublin. This role will focus on providing Quality Assurance oversight for analytical method transfers, method validation activities, and analytical equipment qualification within a GMP-regulated environment.

This is an excellent opportunity for QA professionals who enjoy working closely with QC laboratories, validation teams, and technical stakeholders to ensure the successful implementation of new methods, equipment, and processes while maintaining compliance with regulatory expectations.

Key Responsibilities

Provide QA oversight for analytical method transfers and validation programs.

Review and approve qualification, validation, and lifecycle documentation for laboratory systems and analytical equipment.

Support implementation of new analytical technologies and laboratory improvements.

Partner with QC, Validation, Engineering, and Technical Services teams to ensure GMP compliance.

Review and approve deviations, CAPAs, change controls, and risk assessments.

Provide QA guidance on validation strategies and regulatory expectations.

Support audit readiness and regulatory inspections.

Requirements

Degree in Science, Pharmacy, Biotechnology, or a related discipline.

5+ years' QA experience within the pharmaceutical or biotechnology industry.

Strong knowledge of GMP, FDA, EMA, and HPRA requirements.

Experience supporting analytical method transfers and method validation activities.

Experience reviewing analytical equipment qualification documentation.

Strong understanding of change control, deviations, investigations, and CAPA processes.

Excellent technical writing and document review skills.

Ability to work effectively across multidisciplinary project teams.

Strong communication and stakeholder management skills.

Eligible to work in Ireland

Why Join CAI?
Join a growing team delivering high-profile QA and validation projects.
Competitive rates, flexible project opportunities, and strong career development.
Be part of Ireland's thriving life sciences sector.

About CAI

CAI is a global leader in commissioning, qualification, validation, and operational readiness services for the pharmaceutical, biotechnology, and life sciences industries. We partner with leading manufacturers to deliver compliant, efficient, and innovative solutions that ensure quality and regulatory excellence.