promeatherapeutics
Job Description: Responsible for preparation of STP,SOP & Specifications. Perform HPLC analysis of raw materials, in-process, stability, and finished product Prepare mobile phases, reagents, standards, and test solutions as per approved methods. Operate, calibrate, and perform routine maintenance of HPLC systems. Responsible for compliance for GLP practices. Responsible for handling of operations and calibrations of Instruments. Responsible for handling of working standards, Reference standards,Primary standards, and controls. Responsible for proper maintaince of stability chamber. Responsible for preparation of Method validation, Method verification,cleaning validation & Stability study protocols and reports. responsible for Sampling,testing and release of RM,PM,IP,FP, Stability & water samples. Responsible for preparation of reagents,Indicators & volumetric solutions. Responsible for final review & release of Analytical Data. Responsible for daily monitoring of temperatures in Laboratory and stability chambers. Responsible for handling of QMS. Responsible for handiling of Incidents,Ratifications & Deviations. Responsible for Initiation & Closing of CCF's.