Identify Calibration Curve Range for specific analytic based on literature search, optimization of chromatographic condition, parameters on LCMS/MS equipment, extraction technique, designing for method development trials.

Assign activities to individual analysts on day to day basis, interpretation of development results and further discuss with SGL for further Trials.

Prepare investigation report for failures/unexpected results.

Project Planning as per the schedule to utilize full machine time.

Perform Analysis

Set-up the required equipment (Mass Spectrometers) for daily analysis

Interpretation of results, investigate any deviation and correct, update progress to SGL.

Execution and maintenance of GLP, safety and quality systems.

Identification of Incurred Sample Re-Analysis (ISR) and Repeat Sample (RS) and submit report to SGL.

Documentation &

Review

Prepare method SOPs, study plan and validation protocol for each molecule and submit to internal QC for their review.

Review the method book and other compiled raw data on daily basis

Compile the calibration data of HPLC and LCMSMS and submit to internal QC.

Prepare incident reports, Deviations, query response for QA/QC/Sponsors





Review of all controlled forms/logs/Laboratory Record Book filled by analysts on daily basis To acknowledge the maintenance performed by engineer,

Review the guidance and follow the practice for routine analysis.

Equipment

Calibration &

Maintenance To perform calibration of HPLC, coordinate with in-house engineering team for calibration of LCMSMS.

Perform preventive maintenance of the system on daily/weekly basis

Coordinate with maintenance engineer team for all preventive maintenance and break-downs, ensure continuous performance of respective equipment.

Maintain schedule of calibration and review the calibration data of other small instruments of sample preparation area.

Communication,

Reporting & MIS

Compile analysis data, fill-up in requisite report template, and submit to respective BQM and Report Writers in a timely manner.

Reply to relevant BQM, /QA queries in co-ordination with team members

Timely update to SGL/BI for study/validation/method development.

Prepare Monthly Equipment Utilization reports, Shift schedules and update

SGL accordingly.

Conduct functional team meeting on weekly basis and join DFMT organize by

SGL/BI.

📌 Analyst Group Leader - Bioanalytical Research (Ahmedabad)
🏢 Veeda Clinical Research
📍 Ahmedabad