Overview:We are working on behalf of a global biopharmaceutical company in Cork who are actively searching for a QA Representative to join them on a 12 month contract basis as soon as possible.What to expect day to day:Provide Quality leadership, direction, and governance for the specific areas of responsibility.Manage quality-related matters specific to area of responsibility.Responsible for approving appropriate quality-related documents.Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documentsReview and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.Requirements:Hons BSc, MSc, or PhD in Pharmacy, Chemistry, Engineering, Quality, or related discipline.Minimum of 3 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.Experience working in cross functional teams and proven ability in decision making.Experience with Quality Management Systems such as Trackwise and MES is a big plus.