Quality Assurance Specialist
This role is crucial for our pharma manufacturing client based in Kerry, Ireland. The position involves developing and managing the quality management system (QMS) for the manufacture of sterile pharmaceutical products destined for the global market.
Key Responsibilities:
* Coordinate QA resources to meet established goals and objectives
* Ensure compliance with QMS requirements through effective management and oversight
* Represent the company during Health Products Regulatory Authority (HPRA) inspections and communicate effectively with regulatory bodies
* Support HPRA inspections and prepare written responses as needed
* Conduct internal compliance audits to ensure operational excellence
* Organize annual supplier reviews to maintain high-quality standards
* Schedule periodic reviews of QMS and operational procedures to ensure regulatory compliance
Requirements:
* Bachelor of Science (Hons) in Science or equivalent qualification
* Proven experience in Quality Management Systems within the pharma, food, or medical device sectors
* Team management experience is desirable but not essential
* This role requires primarily on-site work but may consider hybrid arrangements