Job Description

Job Title



Chemist - GC Analysis





Department



Quality





Sub Department



Quality Control

PURPOSE OF THE ROLE

Responsible to perform GC analysis and document the same in compliance with cGMP, cGLP, EHS requirements and defined operating procedures.

JOB DESCRIPTION

(What the person needs to deliver at workplace)



1.Proper takeover of shift operations as per defined procedure as a reliever.


2.GC Systems & Analysis :


Go through requisite procedures, plan and prioritize activities for the day based on work plan received from supervisor.

Ensure the Cylinder status and GC column fixation and stabilization before starting analysis. Preparation of system suitability solutions, standard solutions and test solutions as defined in the procedures. Calibrate GC Equipment, evaluate system suitability and proceed for further analysis.

Process chromatographs as per procedure and submit the same for review.

100% adherence to cGMP and cGLP practices in line with 21 CFR Part 11. 100% adherence to EHS requirements as applicable to QC laboratory.

Timely reporting of abnormalities/ Deviations to the immediate supervisor/ appropriate authorities.


GC Documentation
+ Record raw data pertaining to system suitability solutions, standard solutions, test solutions, analytical and calibration results.

+ Live recording of each activity, viz., instrument logbook, column usage log, working standard / reference standard / impurities reconciliation.

+ Handover completed documents to reviewer / ongoing documents to reliever.
4.GC Maintenance


Troubleshoot day to day issues with respect to instruments with the support of in- house service engineer.

5.Training


Successful completion of assigned trainings and application of the same at workplace.

QUALIFICATIONS/ EXPERIENCE REQUIREMENTS

Parameter

Minimum

Preferred

Education



B.Sc. (Chemistry)



M.Sc. (Chemistry)





Experience (in Years)



2



4





Nature of Experience



Hands on Experience on Software and Instruments (Make n Model). Need to be aware of quality systems, regulatory and cGMP guidelines, EHS requirements in Pharmaceutical API companies.

COMPETENCY REQUIREMENTS

FUNCTIONAL

Knowledge on Software and Instruments





Analytical Thinking





Quality Focus





Trouble Shooting

BEHAVIOURAL

Attention to detail





Proactive





Problem Solving