Team Member - QC (LCMS)

Job description

Responsibilities Ensuring good laboratory practices (GLP), good documentation practices (GDP) and good manufacturing practices (GMP). To follow the laboratory safety standards and practices. To perform activities related to LCMS instrument and analysis. To ensure that analysis was conducted as per the respective SOP or STP or GTP. For Calibration and Standardization of Analytical instruments. For ensuring the preparation and standardization of Volumetric Solutions, reagents and mobile phase preparations. To report/Highlight discrepancies in- procedures / products / materials /People practices/ Systemic issues to the group leader and functional head on time. To ensure that the documentation done in online and error free. To ensure that only calibrated instruments / equipment’s are used for analysis. To ensure that only valid working / reference / impurity standards are used for analysis. For ensuring the Disposal of samples after the completion of analysis. To ensure that the instruments / equipment’s are used with utmost care and as instructed in the relevant SOP. To report incidents / OOS/OOT on time to the group leader. To ensure Instruments/ Equipment’s and work area should be clean. For maintenance of registers, logbooks used for analysis. Testing of analytical samples as per schedule and submit the reports online to the concern. Responsible for result posting and other SAP and LIMS related activities for sample analysis. For sending the samples to contract laboratory for testing. For documents tagging and submission to QA. For conduct investigation related to notifications. For initiation of change controls and implementation of CAPA and notifications closure on time. Chromatographic data processing in Analyst Software. To ensure the compliance with respect to LCMS instrumental handling and analysis of respective samples. To coordinate during internal / external inspections along with necessary action plans. Ensure to comply any other responsibility given by the reporting authority. M.Sc./M Pharma. Experience: 6 to 10 Years