QA Specialist

About the Role

CAI is searching for a seasoned Quality Assurance Specialist to support a top biotechnology client in Dublin. This position centers on delivering QA oversight for analytical method transfers, method validation processes, and the qualification of analytical equipment within a GMP-regulated setting.

Key Responsibilities

• Oversight of QA activities related to analytical method transfers and validation efforts.
• Reviewing and approving documentation tied to qualification, validation, and lifecycle management of laboratory systems and analytical instrumentation.
• Assisting with the deployment of novel analytical technologies and enhancements within the laboratory environment.
• Collaborating with Quality Control, Validation, Engineering, and Technical Services teams to maintain GMP compliance.
• Evaluating and endorsing deviations, CAPAs, change controls, and risk evaluations.
• Providing QA expertise on validation strategies aligned with regulatory standards.
• Supporting preparedness for audits and regulatory inspections.

Candidate Requirements

• A degree in Science, Pharmacy, Biotechnology, or a closely related field.
• Minimum of five years QA experience in pharmaceutical or biotechnology sectors.
• In-depth knowledge of GMP regulations and regulatory bodies such as FDA, EMA, and HPRA.
• Experience in supporting analytical method transfer and validation projects.
• Familiarity with reviewing qualification documentation for analytical equipment.
• Comprehensive understanding of change control, deviations, investigations, and CAPA procedures.
• Strong skills in technical writing and document assessment.
• Ability to collaborate effectively within multidisciplinary teams.
• Excellent communication capabilities and stakeholder relationship management.
• Must be authorized to work in Ireland.

Why CAI?

• Work within a growing team handling prominent QA and validation projects.
• Access to competitive remuneration, flexible project engagements, and opportunities for professional growth.
• Be part of Ireland's dynamic life sciences sector.

About CAI

CAI is recognized globally for expertise in commissioning, qualification, validation, and operational readiness for the pharmaceutical, biotechnology, and life sciences industries. We collaborate with leading manufacturers to provide compliant, innovative, and efficient solutions ensuring quality and regulatory adherence.

Additional Information

CAI may utilize artificial intelligence tools during the recruitment process to assist in application analysis, resume evaluation, and response verification. These tools support but do not replace human decision-making, with final hiring choices determined by human judgment. For inquiries regarding data processing, candidates are encouraged to contact CAI directly.