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
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