Quality Systems Specialist

My client, a global pharmaceutical company in Wicklow, is currently recruiting for a Quality Systems Specialist to join their team. This is a full time, permanent position and will report directly to the QA Compliance Manager. Some benefits below: · Hybrid working available - 2 days per week at home, 3 on site · Flexi time · VHI health insurance · Pension · Subsidised Canteen · Education assistance QA Quality Systems Specialist is responsible for the management and continuous improvement of harmonised Quality Management Systems (QMS) contributing to the quality of processes and products. · Support the ongoing management of electronic Quality Management Systems(eQMS) related, but not limited to the following processes: Documentation management, Change controls, Deviation management, CAPAs, Customers complaints and Laboratory Investigations. · Lead and execute development and /or modification of the company’s eQMS. · Develop and approve any written procedures and other documents including amendments to those documents (e.g. SOP’s WISOP’s Technical agreements, Quality Policy and other compliance related documents.) required in support of eQMS. · Develop and maintain dashboard reports ensuring accurate, complete, and consistent data is available providing meaningful trending and analysis of data across all quality systems. · Participate in the preparation of and delivery of associated training on site. · To collaborate with the corporate Quality Systems Specialist to contribute to the development maintenance of the quality systems. · Work collaboratively with all site departments to ensure high levels of GMP. · Participate in the preparation of and follow up of regulatory and other external inspections of SII Position Requirements Essential:

• 3+ years’ experience in the Pharmaceutical Industry and a 3 rd level qualification in a scientific discipline.
• Strong communication skills and interpersonal skills
• Strong IT skills
• Strong writing skills
• Strong attention to detail