Job Description
Job description: Process Quality Technician responsible for ensuring quality management systems and regulatory compliance in a medical devices and pharmaceuticals company.
Fannin Limited, part of DCC Vital, is a leading provider of medical devices, pharmaceuticals, and diagnostic products to healthcare professionals and patients across the Island of Ireland and the UK. With a heritage dating back to 1829, the company has a track record in medical supplies and pharmaceutical distribution.
The successful candidate will support the Quality Management Systems and maintenance of Good Manufacturing Practice (GMP), Good Documentation Practice (GDoc P), and Regulatory compliance for Fannin Ltd. through activities such as:
- Ensuring Standard Operating Procedures and work instructions are documented to company, ISO, and other applicable standards and/or regulations
- Assisting in the design and completion of validation projects and site projects
- Ensuring manufacturing conforms to management system requirements in relation to quality and health and safety compliance
- Supporting manufacturing investigations/root cause analysis and implementation of CAPA management
- Performing review and approval of manufacturing documentation to ensure product meets required specifications
- Supporting manufacturing training plan to ensure compliance to the QMS and GMP
- Supporting the management and maintenance of Environmental monitoring in relevant manufacturing areas
- Actively supporting in the preparation and participation in Internal and External Audits
- Leading site projects and process improvements as directed by senior management
The ideal candidate will have a relevant Third Level qualification and experience in GLP, GMP, GDP, and/or ISO environments. Desirable qualifications include Auditor Certified (e.g. ISO9001) and knowledge of Environment, Health & Safety Legislation and regulations.
Key characteristics include:
- Pro-active and flexible with a strong ability to interface effectively with all levels within the company and organizations outside Fannin
- Proven problem-solving and trouble-shooting skills
- Strong oral and written communication skills
- Strong interpersonal and leadership skills
- Ability to plan and prioritize work to meet commitments aligned with production priorities