Primary

Responsibility Description

Research &

Development

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.

Guide and explain to avoid the failure and root cause analysis in practical challenges.

Team handling/team development

Conduct training of Analysts for assigned activities like sample preparation,

Batch submission, online documentation, Equipment handling and troubleshooting etc.

Guide analyst for method development and trouble-shooting during analysis.

Continuously provide guidance to analyst for areas like safety, GLP,

documentation etc.

Conduct trainings on SOPs, Bio-analytical Study Plan, Method Validation Plan,

clinical updates and Protocol for Analysts.

Ensure Training Records/training of Group members for timely completion To groom analyst to take up higher responsibilities within organization

Responsible for approval of attendance and leaves of analyst group.

Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances.

s and probation confirmation of recent joinee.

Responsible to manage departmental work in absence of reporting manager.

Any other task assigned by reporting authority.

Customer

Satisfaction

Sponsor satisfaction in terms of services provided by survey internal stakeholder or external.

📌 Analyst - Group Leader / Junior Group leader (Ahmedabad)
🏢 Sarita Devi
📍 Ahmedabad