Executive

Job description

• To Access Study Plan and Standard Operating Procedures and to comply with
• instructions given in Study Plan and Standard Operating Procedures.
• To record raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice, review of raw data and are responsible for the quality of their data.
• Operation Maintenance and Calibration of Liquid Chromatography and Tandem Mass Spectrometer (LC/MS/MS).
• To perform the method Development, method validation and study sample analysis (non-clinical) for GLP Studies.
• Preparation of ATP (Method SOP), SOPs, Template for GLP Studies.
• Sample preparation for MD, MV and study analysis as per GLP guidelines.
• Pipette Maintenance and calibration assigned to the group.
• Other job responsibilities assigned by reporting authority.
• Preparation of method validation/partial method validation reports and bioanalytical study reports for GLP studies in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP.
• Documentation of any type of Deviation in GLP study report communicated directly to the Study Director and/or if appropriate, the Principal Investigator.
• Responding to QA observations for bioanalytical reports in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP.