Senior Quality Specialist
Senior Quality Specialist
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Job Description
Eurofins BPT are actively seeking a Senior Quality Specialist to join our Quality team in Dungarvan Co Waterford.
The purpose of this job is to support the implementation and development of the Quality System in the company.
- Continuous improvement of Quality Management System including but not limited to internal audits supplier management change control exception systems.
- Prepare agenda for weekly Quality Meetings to include metrics on number of documents pending review etc.
- Deputise for the Quality Manager as requested in terms of review and approval of documentation and supervision of staff as necessary
- Responsible for ensuring all internal and supplier audits are completed as scheduled
- Management of Controlled Drugs
- Operation and maintenance of the Exceptions system.
- Coordinating the resolution of issues surrounding nonconforming work as necessary with Laboratory Management.
- Completion of internal audits.
- Operation and maintenance of the Audits module within LIMS.
- Support the coordination and compilation of client audit and regulatory inspection responses.
- Support the coordination and compilation of information for regulatory bodies as requested.
- Support the hosting of client audits and regulatory inspections point of audit set up Quality Department representative during audits.
- Proposing and implementing improvements to the quality system in line with industry best practices and standards.
- General upkeep of the quality system through a plan of continuous improvement from CAPAs audits review of procedures and regulatory/legislation updates.
- Review and Coordination of technical and quality agreements.
- Coordinating and submitting information to clients as requested questionnaires requests for regulatory information.
- Operation of the Supplier Approval system.
- Administration and control of external documentation including client methods and SMIS.
- Delivery of quality systems training as required.
- Assist in the preparation and delivery of the Annual Management Review process.
- QA approval of procedures and protocols.
- QA approval of certificates of analysis and technical reports.
- QA approval of Exceptions.
- Controlled Drugs :
- Responsible for the activities related controlled drugs system across site
- Obtaining / maintaining licences for possession or import or export of controlled drugs as necessary
- Point of contact for the HPRA in relation to the activities involving controlled drugs management on site which includes but not limited to reconciliation stock returns maintenance of licences adherence to procedures and compliance to the legislations.
Qualifications :
Education / Qualifications
- Bachelors degree in a scientific discipline Quality Science engineering or other relevant scientific or technical discipline.
- 5 years experience in a laboratory in GMP regulated environment with at least 2 years of QA role experience is desirable.
- Working knowledge of pharmaceutical quality systems
- Ability to work independently or as part of a team.
- Excellent report writing communication and organisational skills.
- Quality oriented with the ability to consistently work to industry and client standards.
- Positive and tenacious approach to work.
- Highly organised methodical and systematic approach to work.
- Passionate about quality and customer service.
- Good communication skills both internally and externally. Ability to understand clients requirements and to be able to devise and articulate the most appropriate solutions.
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 61000 staff across a network of more than 1000 independent companies in over 61 countries and operating more than 900 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 2022 Eurofins generated total revenues of EUR 6.7 billion and has been among the best performing stocks in Europe over the past 20 years.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
