Chemist - GC Analysis

The Chemist GC Analysis is responsible for performing GC analysis and documenting the same in compliance with cGMP, cGLP, EHS requirements, and defined operating procedures. You will be required to properly take over shift operations as per defined procedures as a reliever. In terms of GC Systems & Analysis, you will need to go through requisite procedures, plan and prioritize activities based on the work plan received from the supervisor. It is essential to ensure Cylinder status and GC column fixation and stabilization before starting the analysis. Additionally, you will be responsible for the preparation of system suitability solutions, standard solutions, and test solutions as defined in the procedures. Calibration of GC Equipment, evaluation of system suitability, and submission of chromatographs for review are also part of your responsibilities. You must adhere 100% to cGMP and cGLP practices in line with 21 CFR Part 11 and EHS requirements applicable to the QC laboratory. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authorities is crucial. Regarding GC Documentation, you are required to record raw data related to system suitability solutions, standard solutions, test solutions, analytical and calibration results. Live recording of each activity, including instrument logbook, column usage log, working standard/reference standard/impurities reconciliation, is essential. Handing over completed documents to the reviewer/ongoing documents to the reliever is also part of your duties. In terms of GC Maintenance, troubleshooting day-to-day issues with respect to instruments with the support of an in-house service engineer is important. Successful completion of assigned trainings and application of the same at the workplace is also required. The minimum educational requirement for this role is a B.Sc. in Chemistry, while a preferred qualification is an M.Sc. in Chemistry. A minimum of 2 years of hands-on experience on Software and Instruments (Make n Model) is required, with a preference for 4 years of experience. The candidate should be aware of quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies. Competency requirements for this role include functional knowledge on Software and Instruments, analytical thinking, quality focus, and trouble-shooting skills. Behavioral competencies required are attention to detail, proactive attitude, and problem-solving skills.,