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الوصف الوظيفي

Company Description

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.


With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.



Job Description

Job description:


  • Extractable and Leachable analysis experience in CCS as per USP monograph and   medical devices testing as per ISO guidelines
  • Operational/ handling experience in GC-MS/MS, LC-MS/MS, ICPMS and maintaining the data management system.
  • Handling and processing of the data from GCMS and LCMS. Must have Mass hunter or equivalent software experience.
  • Experience in Method development by LC-MS and GC-MS. Interpretation of mass spectra and proposing probable structures for impurities.
  • Preparation and Implementation of SOP’s related to E& L , general laboratory processes and best guidance.
  • Good knowledge of 21 CFR part 11, Data Integrity principals, good documentation practices in cGMP lab.
  • Good laboratory practices/ documentation/ implementation of SHE rules. 
  • Excellent team player and execute day-to-day activities to complete the time bound tasks.
  • Minimum 4 years of experience in analytical lab handling MS instruments and data review
  • Excellent team player , communication, compliance knowledge is must.

Qualifications

M.Sc - Analytical Chemistry /Organic Chemistry/General Chemistry/Industrial Chemistry





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