Our client is an indigenous Pharmaceutical organisation based in Dublin who sell & distribute healthcare products across Ireland & the UK. They are currently seeking an experienced Quality Manager who will be responsible for managing the processes and systems to ensure that the company is in compliance with all applicable regulatory and business requirements.
• Lead our clients Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review.
• The Quality Manager is responsible for overall development, implementation, and maintenance of the organisation’s Quality Management System (QMS).
• Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation.
• In collaboration with the Management Team, drive continuous improvement and best practices in our clients Quality systems.
• Responsible for ensuring adherence to all external regulatory requirements.
• Manage internal and external audits.
• Maintain and follow up CAPAs.
• Prepare reports on Quality System performance as required.
• Enhance a compliance culture throughout the business.
• Build and maintain an ISO13485 Quality System incorporating the company’s existing medicinal QMS.
• Prepare and maintain documentation in compliance with the appropriate regulatory requirements.
• Act as our Responsible Person for Medicinal Products under the company’s Wholesale Distribution Licence (WDA).
• Adapt existing procedures and documents that best meet the requirements of QS and the workflow within the Company. Create new Standard Operating Procedures, as required.
• Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements.
• Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals.
• Provide Quality and Regulatory inputs into Clinical studies.
• Third level qualification in an Engineering or Science Discipline.
• An additional qualification in Quality Assurance is desirable.
• At least 5 years post-graduation experience in Quality environment with at least 3 years at a similar level.
• Experience in management of Quality Systems in a Medical Device/Pharmaceutical Industry.
• Excellent knowledge of ISO 13485 environment.
• Experience in the preparation of Technical Documentation.
• Experience in CAPA system management.
• A working knowledge of FDA requirements and managing FDA audits is desirable.
• Six Sigma training desirable.
• Regulatory experience and knowledge in the following areas; medicinal, medical, cosmetic and food supplement.
• Good supervisory, technical writing and investigation skills are required.
• Excellent communication and inter-personal skills.
• Strong planning and organizational ability.
• The ability to carry out work in a fast-paced organisation.
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256