QA Process Specialist My client, a Global Leader in the Pharmaceutical market is looking to recruit a Quality Assurance Process Specialist to join their QA Team on a permanent basis. Reporting to the QA Team Lead, the QA Process Specialist will be working closely with the business functions to provide QA support. Key Responsibilities Ensure all quality systems are implemented / executed in compliance with ICH Q7 and site quality standards. Review and approval of Manufacturing and Cleaning Batch Documentation and associated equipment logbooks in accordance with cGMP Batch disposition and preparation of certificates of analysis Pre-operative and routine inspections of the plants and facilities - shop floor presence. Review and approval of GMP SOP's, change controls and deviations. Participate in customer and regulatory inspections: Preparation of Campaign reports, Process Validation Reports, Process Verification Reports and Annual Product Reviews Compilation of Process and Cleaning validation protocols and reports. Communicate with all departments on site on a regular basis to ensure timely approval, use and shipping of product Support the introduction of New Products to site. The QA Process specialist will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role. The QA Specialist will be committed to; Continuous improvement projects Leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site *This position requires previous hands on experience working with small molecule API* Education/Experience The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 3 years pharmaceutical experience ideally in a QA role. The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task. For more information please contact Jack on 01-6455250, or click apply below!