We are seeking an experienced Senior Quality Assurance Specialist to join our team in a high-impact role. The successful candidate will play a pivotal part in building, embedding, and evolving our quality systems, culture, and operational excellence.
As a key member of our Quality Assurance team, you will report directly to the Director of Quality and have real influence across all aspects of site QA. Your responsibilities will include:
1. Supporting the design and ongoing improvement of our Quality Management System (QMS) in line with Good Manufacturing Practice (GMP) and Health Products Regulatory Authority (HPRA) expectations
2. Managing change control, document control, Corrective Action Preventive Action (CAPA), and deviations, ensuring robust root cause analysis and effectiveness checks
3. Ensuring data integrity, traceability, and compliance across all quality records
4. Acting as QA lead during internal/external audits (HPRA, customer, etc.)
5. Leading site-wide risk assessments (ICH Q9), and implementing risk-reducing improvements
6. Delivering and tracking GMP training, mentoring junior QA staff and cross-functional teams
To be successful in this role, you will require:
* A Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a similar field
* 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
In return for your expertise and passion for quality assurance, we offer a competitive compensation package that includes:
* A challenging and rewarding role with opportunities for growth and development
* A dynamic and collaborative work environment
* The chance to make a meaningful impact on the quality of our products and services