Interim Quality Engineer

• 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:

• Lead complaint management and ensure completion of CAPA's in the required timeframe
• Support site investigations and CAPA management (complaint investigations and Non-conformances)
• Support issues management (Recalls, Complaints, and Vigilance)
• Assist and develop in house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files etc.
• Support completion of audit schedule
• Coordination of KPIs for issues, audits and CAPAs
• Support quality risk management under ISO 14971
• Delivery of relevant training requirements such as Quality, GDocP, and GMP
• Support management and continual improvement of systems such as Change Control & Process Deviation
• Knowledgeable of ISO 9001 & ISO 17025 standards
• Advise, facilitate, and implement systems to ensure continuous improvement of processes & services
• Lead/support site compliance to IVDR (EU) 2017/746.
• Support the maintenance of the Environmental, Health & Safety System management for Fannin Ltd.
• Maintain an in-depth knowledge of the business and products, the customers, suppliers, and the market dynamics.
• Support of projects, sharing knowledge and providing expertise.
• Report incidents, field safety notices and pharmacovigilance issues to head office quality department when required.
• Support the preparation and submission of data for monthly, quarterly, and annual reports (KPIs), and assist with management review preparation.
• Assist with the preparation and participate in/lead Internal and External Audits (e.g SGS, HPRA, INAB & Customer Audits).

• Manage and maintain good professional working relationships both internally and externally to the business.
• Provide cover for other team members as required.

• Relevant Third Level qualification
• Experience in GMP, GDP and/or ISO environments

• Working knowledge of IVDD 98/79/EC and IVDR (EU) 2017/746
• Experience of regulatory body liaison e.g. the HPRA, MHRA
• Auditor Certified (e.g. ISO9001 and/or ISO17025)
• Knowledge of Irish H&S and Environmental Legislation and regulations
• QMS software systems experience
• Validation experience
• Risk management experience
• Clinical Microbiology/Microbiology qualification

• Pro-active
• Flexible and adaptable to changing environment
• Ability to interface effectively with all levels within the company as well as organizations outside Fannin (regulatory agencies)
• 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 organisational goals.

DCC