The successful candidate will be responsible for maintaining the Quality Management System, building relationships with our Heads of Departments, and colleagues in Eurofins Biomnis, Eurofins Pathology, and Eurofins Lablink.Specific TasksUse of the Laboratory Information Management Systems in place in the laboratory.Ensuring, in conjunction with the Quality team, that the laboratory and Logistics division operates within the company’s quality management systems to meet the requirements of ISO15189 accreditation and ISO9001 certification, the Eurofins Group policies and any relevant regulatory requirements.Maintain ISO9001 certification and associated QMS.Support the existing Quality team and maintain the company’s quality management system (QMS).Assist in the creation, review and approval of internal quality documents as per company’s procedures for document control. Support to the existing Quality team with client requests.Conduct internal audits and participate in external audits (e.g. assessment bodies, clients).Conduct external audits (as directed by the Quality Manager).Preparation and submission of documentation to the external bodies in advance of external audits e.g. INAB, NSAI. Preparation and submission of documentation as clearance to non-conformities raised within the agreed timeframe.Oversee the management of the quality system records, storage and archival processes.Provide quality direction, oversight and continual improvement for new and existing processes and systems ensuring implementation activities are robust and timely.Carry out training on the QMS and QPulse for new and existing employees.Assist in the development and tracking of critical quality processes such as CAPA, complaints, internal/external audit findings, and non-conforming reports.Assistance with the clearance of non-conformities raised in quality audits, incident reports raised and investigation of complaints and their effectiveness.Assist in the maintenance of current modules and the development of additional modules on QPulse.Participate in process / continuous improvement initiatives.Assist in the development, management, maintenance and analysis of departmental Key Performance Indicators (KPI’s).Review and approval of assay and equipment verifications.Liaise with the various departments on change control and inform the various departments. Prepare and submit INAB as required.Assist the various departments in the management of equipment (including the Temperature Monitoring System). Oversee equipment calibration and performance review.Organise and carry out meetings with the various departments as assigned by the QA Manager. Organise (in conjunction with the quality manager) and assist the various departments in the preparation of the Annual Management Review Meetings and preparation for external audits.Perform other Quality System duties and involvement in any other projects relating to standard requirements as assigned by the QA Manager.Hours per week: 35Please note this is not a HYBRID role, this role will be based on site in Sandyford, Dublin 18QualificationsA 3rd level qualification in Quality Assurance and/or a science discipline is a distinct advantage; however, a combination of experience and training will be relevant for the role.ExperienceCandidate should have at least 2 - 3 years Quality Assurance experience in a clinical diagnostic laboratory or similar role.Knowledge of QPULSE would be an advantage.Understanding of ISO15189 accreditation and ISO9001 certification.Experience in INAB Audit/Accreditation process.Skills & AbilitiesStrong communication and interpersonal skills.Demonstrate ability to evaluate information, solve problems and make effective decisions.Demonstrate ability to identify and resolve systems failures and anomalies.Evidence of strong commitment to the provision of a quality service.We are part of the Eurofins Scientific Group, a global leader in food, environment, pharmaceutical, forensics, clinical diagnostic, cosmetic product testing and in agroscience. The Group operates more than 900 laboratories in over 50 countries and employs 55,000 staff conducting 450 million tests every year.Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.Your data:As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.Eurofins Biomnis is an equal opportunities employer.
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