Releaser, QA

A Quality Batch Releaser is responsible for carrying tasks pertaining to compliance and product quality. Providing quality oversight and ensuring compliance with regulatory requirements. This role is required to collaborate with all relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This will include batch disposition, documentation management and approval, product record review, investigations, complaints, change controls, audits, stability, and regulatory support. Sterile batch and patient specific products are manufactured using isolator and/or LAF technology and/or CDSC technology in a clean room environment. It is the responsibility of the Qualified Person / batch releaser to ensure that all products released from the Dublin Compounding Facility follow the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.