Process Quality Technician
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:
- Ensure that Standard Operating Procedures and work instructions are documented to company, ISO and other applicable standards and/or regulations
- Assist in the design and completion of validation project, and site projects
- Ensure manufacturing conforms to management system requirements in relation to quality, and health and safety compliance
- Support manufacturing investigations/root cause analysis and implementation of CAPA management
- Support 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 GMP
- Support the management and maintenance of the Environmental monitoring in relevant manufacturing areas.
- Actively support in the preparation and participate in Internal and External Audits
- 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.