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GMP Scientific Data Reviewer - Gene Therapy

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Job Description - GMP Scientific Data Reviewer - Gene Therapy

Company 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.

What can Eurofins offer you?

  • At Eurofins we offer careers not just jobs. 
  • Developmental opportunities and career progression
  • Private Medical Insurance when with the company for 2 years for all roles
  • 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

We are seeking a Data Reviewer to join our exciting Gene Therapy team in Dungarvan Co Waterford.

3+ years' GMP Pharma experience is required to apply for this role. 

The purpose of this job is the data review of scientific test procedures used on client samples ensuring that accurate results have been produced. This person will also work to develop any ancillary procedures associated with the processes used; ensuring customer samples are completed within their required specifications. 

Responsibilities 

  • Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
  • Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
  • Data Reviewers are permitted to sign all technical documents within the company once their training in this task is successfully completed.  This includes laboratory reports, SOPs, protocols, investigation reports and any other documentation issued.
  • This person will perform analytical testing when not engaged in Data Review activities. 
  • This person will ensure that all documentation is completed on time, accurately and legibly.
  • Responsible for updating any relevant documentation as required.
  • Responsible for handling any customer related queries where necessary and liaising with their team to problem solve these queries if needed.
  • To keep their training records up to date and to initiate training as per their training plan where possible when free from work
  • To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
  • To ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
  • To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement

Qualifications

  • Degree in Chemistry, Biotechnology, Pharmacology, Molecular Cell Biology, Virology, Biochemistry or  or relevant Scientific discipline 
  • 4+ years' experience in GMP Pharma Laboratory
  • Cell based assay, qPCR and sequencing experience required
  • Previous Data review experience in a GMP environment required.
  • Experience with HPLC and/or LC-MS an advantage
  • Good team player, organised, accurate and strong documentation skills.
  • Strong attention to detail
  • Passionate about quality and customer service
  • Good communication skills both internally and externally

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 61,000 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 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 2024, Eurofins generated total revenues of EUR €6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

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