Senior Quality Administrator

Company Description

****We have a fantastic opportunity for a Senior Quality Administrator to join our Eurofins BPT Dungarvan**** 

Consider joining Eurofins where people are the most important element in our business.  Eurofins Biopharma Product Testing is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.

What can Eurofins offer you?

• At Eurofins we offer careers not just jobs. 
• Developmental opportunities and career progression
• Income protection and life assurance
• Free parking onsite
• Additional annual leave days with continued service
• The opportunity to work on life saving products
• Work-life balance
• Sports and Social events

Job Description

The primary function of the role will be the use of the electronic Document Control systems and to work as part of the Quality Department to support Quality Systems. The person should have good knowledge of GMP specifically with regard to issue and version control of documents.

• As with all members of staff, this person is responsible for ensuring that the customer's requirements are fully met and in doing so, will be flexible to work in any area of the business as required.
• Manage annual notebook and logbook preparation and distribution.
• Participate in writing, investigation and conclusion of any Quality Systems related exceptions, along with CAPA ownership and action completion.
• Process documentation requests from clients.
• Responsible for adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
• Responsible for keeping relevant section of Quality Metrics board up to date.
• Responsible for SMIS and MCSS upload to eLIMS.
• Support Change Control administrative duties.
• Support uploading and archiving of the Technical Agreements process.
• Support uploading and assigning actions to eLIMS for internal and external/regulatory audits.
• To act on their own initiative and to learn as quickly as possible any tasks that they are required to do.
• To assist Administration with archiving of Quality documentation.
• To attain a more detailed understanding of the company's Quality Systems, including possible deviations.
• To be responsible for proficiency in certain procedures/training modules as specified in their training plan.
• To carry out training with personnel on the use of the Document Control system.
• To contribute to process improvement projects as required.
• To deliver Quality Systems training as required.
• To ensure continuous improvement of the Document Control systems occur.
• To ensure procedures relating to Document Control system are accurate and revised as needed to maintain on-going compliance of the system.
• To ensure procedures relating to role are accurate and revised as needed to maintain on-going compliance of the system.
• To gain an insight into the processes/procedures of the company's business including customer awareness, safety and efficiency.
• To generate and issue laboratory logbooks and notebooks.
• To have oversight of the documentation system, ensuring that released documents are checked, effective documents are actioned i.e. company general procedures are replaced in the hardcopy folders, Note-to-Files are actioned.
• To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.
• To keep their training records up to date and participate in training as required.
• To liaise with other team members to ensure the best practices are used along with the facilitation of changes, as requested by the company.
• To maintain the Document Control systems to ensure documentation is controlled, distributed and archived in accordance with company procedures.
• To maintain the training function on the Document Control system, ensuring to assign and complete training correctly along with management of course documentation.
• To own the Periodic Review process, ensuring that all reviews are scheduled in a timely manner to allow the owners enough time to review and update their documents as required.
• To perform routine client communications on Document Control related issues.
• To provide and receive cross-training within the group to ensure key essential services are maintained at all times.
• To provide LIMS support by entering required information entered onto the document management module.
• To provide metrics to management with regard to the Document Control system in relation to status of documents and personnel training.
• To raise any Requests for Change (RFC)