Senior Quality Assurance Specialist

Athlone, Co Westmeath
Permanent
Full-time

1 month ago

Senior Quality Assurance AssociateOur client is a GMP-certified pharmaceutical site based in Athlone, specialising in innovative, plant-based active pharmaceutical ingredients, including products with controlled drug status.The Opportunity:This is a rare chance for an experienced Quality Assurance professional to step into a high-impact, senior-level position at a new, tightly regulated GMP site.As Senior QA Associate, you will play a pivotal role in building, embedding, and evolving the site's quality systems, culture, and operational excellence. Reporting to the Director of Quality, you'll have real influence across all aspects of site QA - from audits, change control and deviations, to training, risk management, validation, and cross-functional collaboration.Key Responsibilities:

Support the design and ongoing improvement of the QMS in line with GMP and HPRA expectations.
Manage change control, document control, CAPAs, and deviations, ensuring robust root cause analysis and effectiveness checks.
Ensure data integrity, traceability, and compliance across all quality records.

Act as QA lead during internal/external audits (HPRA, customer, etc.).

Lead site-wide risk assessments (ICH Q9), and implement risk-reducing improvements.
Deliver and track GMP training, mentor junior QA staff and cross-functional teams.
Champion a culture of continuous quality improvement.

Requirements:

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or similar.
5+ years' experience in GMP QA, ideally in API or pharmaceutical manufacturing.
Strong working knowledge of GMP, HPRA regulations, quality systems, CAPA/deviation handling, and training.

Morgan McKinley

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