Location: Fannin Limited, Ballybrit Upper, Galway, Ireland
Department: Production/Quality
Reporting to: Site Quality Manager
Principal 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:
o Ensure that Standard Operating Procedures and work instructions are documented to company, ISO and other applicable standards and/or regulations
o Assist in the design and completion of validation project, and site projects
o Ensure manufacturing conforms to management system requirements in relation to quality, and health and safety compliance
o Support manufacturing investigations/root cause analysis and implementation of CAPA management
o Support management improvements of QMS documentation (i.e. Change Requests, Process deviations etc).
o Perform review and approval of manufacturing documentation to ensure product meets required specifications.
o Support manufacturing training plan to ensure compliance to the QMS and GMP
o Support the management and maintenance of the Environmental monitoring in relevant manufacturing areas.
o Actively support in the preparation and participate in Internal and External Audits
o Lead 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 objectives
* Advise, facilitate, and implement systems to ensure continuous improvement of processes
Requirements:
* Relevant Third Level qualification
Desirable Qualifications:
* Experience in any of the following - GLP, GMP, GDP and/or ISO environments
* Auditor Certified (e.g. ISO9001)
* Knowledge of Environment, Health & Safety Legislation and regulations
* QMS software systems experience
* Clinical Microbiology/Microbiology experience/qualification
Desired Characteristics:
* Pro-active
* Flexible and adaptable to changing environment
* Ability 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 skills
* Strong oral and written communication skills
* Strong interpersonal and leadership skills
* Ability 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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