Executive

3 days ago

Tandalja Vadodara Gujarat, India Sun Pharmaceutical Industries Ltd Full time

**GLP Bioanalytical**

To Access Study Plan and Standard Operating Procedures and to comply with

instructions given in Study Plan and Standard Operating Procedures.

To record raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice, review of raw data and are responsible for the quality of their data.

Operation Maintenance and Calibration of Liquid Chromatography and Tandem Mass Spectrometer (LC/MS/MS).

To perform the method Development, method validation and study sample analysis (non-clinical) for GLP Studies.

Preparation of ATP (Method SOP), SOPs, Template for GLP Studies.

Sample preparation for MD, MV and study analysis as per GLP guidelines.

Pipette Maintenance and calibration assigned to the group.

Other job responsibilities assigned by reporting authority.

Preparation of method validation/partial method validation reports and bioanalytical study reports for GLP studies in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP.

Documentation of any type of Deviation in GLP study report & communicated directly to the Study Director and/or if appropriate, the Principal Investigator.

Responding to QA observations for bioanalytical reports in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP.

**GLP Statistician**

To prepare PK/TK reports promptly and accurately and in compliance with the Principles of Good Laboratory Practice for Method validation, GLP Studies (non-clinical), review of PK/TK report and are responsible for the quality of their data.

Responding to QA observations for PK/TK reports in consultation with Study Director/Principal Investigator and in compliance with the Principles of GLP.

Other job responsibilities assigned by reporting authority.

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