Quality Systems Specialist

Quality Systems Specialist An opportunity has arisen for a Quality Specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational based in the North Munster region. Key Responsibilities: * Provide leadership, regarding the validation standards required for Process, Cleaning, Water and Equipment. * Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.

* Laboratory QA oversight * Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. * Annual Review System Management * Creation, review and approval of Site Quality documentation including * Review and approve Supplier Change Evaluation documentation. * Investigate Supplier and Customer complaints * Filing & Licence maintenance and Regulatory Requests ...