Senior Quality Administrator
Senior Quality Administrator
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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 customers 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 companys 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 companys 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) for EtQ Document Control and Training Modules as required.
- To represent department at cross-functional initiatives and projects.
- To support cross-functionally within the department.
- To support on-site GMP inspections and client audits.
- To support the backroom for Regulatory audits.
- To track scan and file Quality Systems documentation.
- To train junior Quality Administrator members of staff in tasks for which they have approved training records and are proficient in as required.
Qualifications :
- Science or quality assurance qualification with industrial experience in GMP environment preferable but not essential.
- Administration experience preferable but not essential.
- Minimum 36 months relevant GMP experience without tertiary qualification in related discipline and fully competent in all tasks associated with the role OR 2 years relevant experience with level 6 in related discipline and fully competent in all tasks associated with the role.
- Ability to work independently or as part of a team.
- Excellent communication and organisational skills.
- Quality oriented with the ability to consistently work to industry and client standards.
- Highly organised methodical and systematic approach to work.
- Passionate about quality and customer service.
- Good communication skills both internally and externally.
- Ability to understand customers requirements and be able to devise and articulate the most appropriate solutions.
- Positive and tenacious approach to work.
- Good competence in computer skills.
Additional Information :
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 63000 staff across a network of more than 1000 independent companies in over 60 countries and operating more than 950 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 6.95 billion and has been among the best performing stocks in Europe over the past 20 years.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
