Quality Compliance Specialist

This job has now expired please search on the home page to find live IT Jobs.

The Company:One of the top 20 largest pharmaceutical companies in the world by revenue are currently looking for a Quality Compliance Specialist to be based on their new start up site in West Dublin. They provide treatments for some of the most life-threatening illnesses of our time, delivering a quality of life that would have been unthinkable mere decades ago. What you will be doing? The Quality Compliance Specialist is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Systems and Compliance Manager. Some key tasks and responsibilities are outlined below. Provide oversight and management of key elements of the Quality Management System (QMS) within the compliance group, which includes, Product Complaints and Risk Management. Supporting other elements of the compliance group, including but not limited to, inspection management, metrics/KPIs, Quality council, product quality communications, Regulatory Compliance.Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site. Be a key member of the on-site audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.Preparation of Key Performance Indicators to align with company and global quality objectives.You're Background: Bachelor's degree in chemistry, biology or a related scientific disciplineA minimum of 10 years working within quality in the pharmaceutical industry.SME in ICH Q9 Risk Management and/or Product Complaints is desirable.Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Thorough understanding of quality systems and cGMP's. For immediate consideration apply with an up to date CV. No CV ready? Not sure yet? Please get in touch for more info. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales