Location:
Fannin Limited, Ballybrit Upper, Galway, IrelandDepartment: Production/Quality
Reporting to:
Site Quality ManagerPrincipal Duties and Responsibilities: Support the Quality Management Systems and maintenance of Good Manufacturing Practice (GMP), Good Documentation Practice (GDocP), Regulatory compliance and ISO certifications for Fannin Ltd
through activities such as:
Ensure that Standard Operating Procedures and work instructions are documented to company, ISO and other applicable standards and/or regulationsAssist in the design and completion of validation project, and site projectsEnsure manufacturing conforms to management system requirements in relation to quality, and health and safety complianceSupport manufacturing investigations/root cause analysis and implementation of CAPA managementSupport management improvements of QMS documentation (i.e. Change Requests, Process deviations etc).Perform review and approval of manufacturing documentation to ensure product meets required specifications.
Support manufacturing training plan to ensure compliance to the QMS and GMPSupport the management and maintenance of the Environmental monitoring in relevant manufacturing areas.
Actively support in the preparation and participate in Internal and External AuditsLead site projects and process improvements as directed by senior management and required by the role.
Work with cross-functional teams to promote health and safety System management, and sustainability objectivesAdvise, facilitate, and implement systems to ensure continuous improvement of processesRequirements: Relevant Third Level qualification
Desirable Qualifications:
Experience in any of the following - GLP, GMP, GDP and/or ISO environmentsAuditor Certified (e.g. ISO9001)
Knowledge of Environment, Health & Safety Legislation and regulationsQMS software systems experienceClinical Microbiology/Microbiology experience/qualificationDesired Characteristics:
Pro-activeFlexible and adaptable to changing environmentAbility to interface effectively with all levels within the company as well as organizations outside Fannin (e.g. IT, suppliers & freight companies)Proven problem solving and trouble shooting skillsStrong oral and written communication skillsStrong interpersonal and leadership skillsAbility to plan and prioritise work to meet commitments aligned with production priorities.
Although the above is a description of the requirements of the role, you may be required to carry out other reasonable duties as the Company may require from time to time.
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