Executive/Sr. Executive - AMV (Analytical Method Validation) & HPLC

Role & responsibilities

• To operate and analyze API, Raw material, in-process and Finish product on HPLC (High performance Liquid chromatograph, UPLC (Ultra performance Liquid chromatograph) and GC (Gas Chromatograph) with respect to specification and to report results of analysis in raw data sheet.

• Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis

• Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area.

• To check all day to day activity related instrumental analysis in QC.

• To perform and check Spectrum/ Chromatograms etc. related to instrumental analysis.

• To perform analytical method validation / Verification / transfer activity as per protocol.

• To perform reconstitute stability study as per protocol.

• Responsible to control and maintain records like protocols, raw data, and report of method validation, method transfer and reconstitute solution stability. Analysis records, usage log books and status labels during day to day Analysis of validation.

• Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature.

• Responsible to maintain record of chemicals, glass wares and other lab items of department.

• Responsible for cleaning, maintenance, and daily calibration of specified instruments.

• Responsible to maintain records of Impurity standards, reference standards and working standards for validation activity.

• Responsible to perform calibration and maintain its records.

• Responsible to Prepare and maintain record of finished product.

• Responsible for cleaning, maintenance, and daily calibration of specified instruments.

• Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification.

• Responsible to Perform analysis of process validation.

• Responsible for maintaining Quality management system related documents.

• Responsible for qualification of working standards and maintenance of its records.

• To investigate the Out of specification or Out of trend if found.

• To monitor the overall activity in the department.