Quality Assurance Professional
A highly skilled Quality Assurance professional is sought after to lead the development and implementation of a Quality Management System in accordance with Good Manufacturing Practice (GMP) and Health Products Regulatory Authority (HPRA) regulations.
Key Responsibilities:
* Design and improve the Quality Management System ensuring alignment with GMP, HPRA expectations, and industry best practices.
* Manage change control, document control, Corrective Action and Preventive Action (CAPA), and deviations ensuring robust root cause analysis and effectiveness checks.
* Ensure data integrity, traceability, and compliance across all quality records.
* Act as Quality 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 Active Pharmaceutical Ingredient (API) or pharmaceutical manufacturing.
* Strong working knowledge of GMP, HPRA regulations, quality systems, CAPA/deviation handling, and training.