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 Tasks
- Use 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 companys 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 companys quality management system (QMS).
- Assist in the creation review and approval of internal quality documents as per companys 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 nonconforming reports.
- Assistance with the clearance of nonconformities 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 (KPIs).
- 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: 35
Please note this is not a HYBRID role this role will be based on site in Sandyford Dublin 18
Qualifications :
Education
- A 3rd level qualification in Quality Assurance and/or a science discipline a distinct advantage however a combination of experience and training will be relevant for the role.
Experience
- Candidate 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 & Abilities
- Strong 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.
Additional Information :
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 55000 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. From the food you eat to the water you drink to the medicines you rely on Eurofins works with the biggest companies in the world to ensure the products they supply are safe their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food environmental pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and in the support of clinical studies.
In over just 30 years Eurofins has grown from one laboratory in Nantes France to over 47000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200000 analytical methods to evaluate the safety identity composition authenticity origin traceability and purity of biological substances and products as well as providing innovative clinical diagnostic testing services as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2024 Eurofins generated total revenues of EUR 6515 billion and has been among the best performing stocks in Europe over the past 20 years
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
Remote Work :
No
Employment Type :
Fulltime