GMP QA Specialist - Data Integrity (Contract)

Morgan McKinley

Carlow

Hybrid

EUR 75,000 - 110,000

Full time

6 days ago

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Job summary

Morgan McKinley is seeking a Specialist, Quality Assurance on an 11-month contract in Ireland. The role emphasizes data integrity (ALCOA), cGMP compliance, and quality systems across batch release and documentation.

You will liaise with QA leads and cross-functional teams to ensure compliant manufacturing and timely reporting. The ideal candidate has 3–5 years in a regulated pharma/biotech setting, strong analytical skills, and experience with deviations, CAPAs, and investigations within quality

Qualifications

Bachelor's degree in a science/engineering field with a focus on quality.
Experience in regulated pharma/biotech environments and quality systems.
Knowledge of GMP and data integrity concepts (ALCOA).

Responsibilities

Ensure data integrity and compliance with cGMP and corporate policies.
Maintain and improve quality records, deviations, CAPAs and change controls.
Collaborate cross-functionally with Manufacturing, Engineering and QA.
Review batch/material documentation and electronic records for release readiness.
Generate quality reports and monitor key metrics for the site.