Eurofins

Senior Specialist Data Review - Biologics (Large molecules)

Bengaluru, KA, IN

In-personFull time roleEarly Career, Senior Level

About 2 months ago

About the Job

Position Summary:
Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations

Essential Duties and Responsibilities:  

  • Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process 
  • Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, compound evaluation and other subjective review based on testing performed; perform complex calculations to verify results
  • Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
  • May serve as technical advisor for analysts with regard to QA/QC of data
  • Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
  • Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
  • Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
  • Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
  • Conducts all activities in a safe and efficient manner
  • Attention to details
  • Works in collaboration
  • Performs other duties as assigned
  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Demonstrate and promote the company vision
  • Regular attendance and punctuality
  • Read and understand analytical procedures
     

About the Company

Eurofins Logo

Eurofins

Luxembourg, Luxembourg

5000 +

<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">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 the environment safer, healthier and more sustainable. From the food you eat 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 is a global leader in food, environmental, pharmaceutical and cosmetic product 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. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, 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. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box">&nbsp;</div> </div>