GMP Analytical Chemistry Data Reviewer

  • Full-time

Company Description

Eurofins Selcia Limited is a contract research organisation and one of the world’s leading providers of custom radiochemistry and isotope labelling services specializing in the synthesis of compounds labelled with carbon-14 and tritium.  We have a proven track record of delivering challenging isotope labelling projects to high quality standards and our customer base throughout Europe, North America and Japan includes many of the leading Life Sciences, Pharmaceutical, Agrochemical and Speciality Chemicals companies. 

We are currently seeking an Analytical Chemistry Data Reviewer with GMP experience to join our Analytical Support Group. The successful candidates will have 2 to 5 years’ experience of analytical data review in a Quality Control laboratory environment, a working knowledge of common analytical techniques such as HPLC, LC-MS etc. as well as being familiar with pharmaceutical Quality Control processes. Whilst not essential, a working knowledge of analytical development and validation activity would be advantageous.

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 58,000 staff across a network of more than 1000 independent companies in over 54 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 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

  • Review QC analytical data generated for Finished Product analysis, Raw Material analysis and validation studies according to pharmaceutical cGMP, including reviewing Method Transfer and Stability Study activities.
  • Perform QC Chemistry OOS/OOT investigations.
  • Compiling of cGMP QC analytical data for inclusion as part of Master Batch Record for product release.
  • Assist with overall completion of QC Deviations, Errors, CAPA plans, change controls and Risk Assessment.
  • Review calibration and qualification data for QC Laboratory Equipment.
  • Write Reports, SOPs and other documentation when required.
  • Prepare COAs of Finished Product and Raw Materials.
  • Engage in intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).

Qualifications

Ph.D or graduate educated with 5 or more years of Analytical Chemistry experience in an industrial environment. A key team player and proactive individual with the ability to successfully deliver results within tight deadlines and a keen attention to detail. You will possess excellent inter-personal and communication skills, combined with a strong customer-focused approach.  The ability to co-ordinate within interdisciplinary teams is important.  In return, Eurofins Selcia Ltd offers an excellent comprehensive total reward package.

Additional Information

Are you the person we are looking for?  If so, please visit our web-site at https://careers.eurofins.com/uk/ for more information on how to apply or send your CV and a covering letter to [email protected] quoting job reference  SEL/95/0122.  The closing date for applications is Monday 25 July 2022. 

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