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 Masshunter 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 7-8 years of experience in analytical lab handling MS instruments and data review Excellent team player , communication, compliance knowledge is must.