Chemist - Gc Analysis

1 week ago

Hyderabad Telangana, India Neuland Laboratories Ltd Full time

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

**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

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