Quality specialist

at  Eurofins Ireland BPT

Company Description
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 48,000 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 200,000 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 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
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.
We have fantastic opportunity for a Quality Specialist within 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.

EDUCATION / QUALIFICATIONS

• Primary degree or equivalent in a related discipline (life sciences, engineering) is desirable but not essential

EXPERIENCE / SKILLS

• At least 2 years’ experience in a laboratory or GMP regulated environment within a QA role 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.
  Qualifications

EDUCATION / QUALIFICATIONS

• Primary degree or equivalent in a related discipline (life sciences, engineering) is desirable but not essential

EXPERIENCE / SKILLS

• At least 2 years’ experience in a laboratory or GMP regulated environment within a QA role 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.

• Operation and maintenance of the Exceptions system.
• Co-ordinating the resolution of issues surrounding non-conforming work as necessary with Laboratory Management.
• Completion of internal audits.
• Operation and maintenance of the Audits module within LIMS.
• Support the co-ordination and compilation of client audit and regulatory inspection responses.
• Support the co-ordination 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.
• Support the controlled drugs system – licences, procedures, legislation and compliance.
• 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.
• Co-ordination of technical and quality agreements.
• Co-ordinating 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.
• Review and approval of calibration and qualification data as required.
• Deputise for the Quality Manager, as requested in terms of review and approval of documentation and supervision of staff as necessary.