About this role
To perform method development and validation studies using LCMS or GCMS techniques. To be able to conduct Extractables/Leachables, Nitrosamines studies using LCMS or GCMS. Responsible for preparation of test procedures, development reports, technical reports, validation protocols and reports.Abilities in qualification, calibration and troubleshooting of analytical instruments. To carry out the investigations in case of deviations, OOT, OOC & OOS.To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable. Preparation & review of SOPs, IOPs and EOPs and provide training whenever required. Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.Must comply with GMP, data integrity & EHSS practices.