Co-ordinates and maintains the site Change Control process to ensure that this key element of the Quality Management System continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required.Essential Duties and Responsibilities: * Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. * Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to; * Deviations * CAPA * Quality Risk Management * Responsible for review and approval of associated change control documents, and other documents such as: * Failure investigations * corrective/preventative action documents * Standard operating procedures * Maintaining the electronic systems used for Change Control, Deviation Management and CAPA. * Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements * Provision of monitoring and trending metrics associated with change control and other site quality systems * Actively participate in continuous improvement initiatives. * Participates in regulatory and customer audits. * Participates in quality risk assessments. * Collaborates with functional departments to resolve issues and maintain compliance * Identify gaps in systems and develop feasible plans for correction * Training of personnel on change control and other quality system processesEducation and Experience: * Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry. * This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our Clients unwavering commitment to combining good science & good business.