01 Oct
|
Magnum Services
|
Ahmedabad
01 Oct
Magnum Services
Ahmedabad
R&D; :-
- 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.
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.
- 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.
Pay: ₹1,000,000.00 - ₹1,500,000.00 per year
Perks
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Work Location: In person
📌 Sr. Group Leader Analyst (Ahmedabad)
🏢 Magnum Services
📍 Ahmedabad