Sr. Executive QC Dahej
22 hours ago
1.0
Sample analysis:
1.1
To perform accurate and reliable analysis of Raw material, Finished Products, In-process samples, stability sample, validation samples (process and cleaning validation), Packaging material and water sample analysis as per method of analysis or protocol.
1.2
To record the procedure of the test performed and observations contemporaneously.
1.3
To review the results against specification / acceptance criteria mentioned in the protocol. If any abnormality to be informed immediately to Section head.
1.4
To review the Method of analysis / worksheet prior to analysis and shall inform to the section In charge for the potential failure (if any).
1.5
Preparation of Standard Test Procedure, Method of Analysis, Specification and Standard Operating Procedure as and when required
1.6
To perform calibration and qualification of QC equipment/ Instruments(s).
1.7
To operate the QC equipment(s).
2.0
Volumetric Solution and Table reagent :
2.1
To prepare volumetric solution and standardization.
2.2
To prepare 'Table reagent' solution.
2.3
To verify volumetric solution and Table reagent solution free from turbidity and fungal growth before analysis.
3.0
Sample Receive:
3.1
To receive the sample along with Test request slip (TRF) or Goods Receipt Notes (GRN). To verify the physical sample condition and sample label against TRF / GRN.
3.2
To allocate the AR. No. in 'Inward register'.
4.0
General :
4.1
To verify the sample details (Product Name, Sample Name, Batch No., Station etc.) before perform the analysis.
4.2
To ensure the current version method of analysis and specification available before analysis.
4.3
To verify the instrument calibration status before perform the analysis.
4.4
At start of the shift inform to operator/ supervisor for requirement of chemical usage in analysis.
4.5
After completion of analysis to maintain the instrument usage log.
4.6
Record the analytical document on line (contemporaneously) and submit to reviewer / section head after completion
4.7
Work completion status to be updated in work allotment logbook.
4.8
To follow good laboratory practices.
4.9
Disposal of Residual Sample, Left over material after testing, expired chemicals.
4.10
Reporting of all above analytical work to section head / In-charge-QC.
4.11
Sample preparation & Related documentation for the sample to be sent to the outside laboratory
4.12
To record the temperature and humidity of quality control area.
4.13
To verify and record the cleaning of quality control area.
4.14
To participate in investigations of OOS / laboratory incident / OOT / deviation.
4.15
To inform the section In charge for the break-down of equipment.
4.16
In case of any abnormal observation noticed during analysis immediately inform to the Section in-charge.
4.17
Any data integrity related observation in the department shall be bring to notice of QC-Head.
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