Research Scientist - E&L

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.