Team Member - QC (LCMS)

Team Member - QC (LCMS)

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.

Qualifications

• M.Sc./M Pharma.

• Experience: 6 to 10 Years