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XYZ
Analytical method Validation
· To conduct analytical method validation activities as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing.
Analytical Method Transfer
· To transfer validated analytical methods to plant locations successfully in order to train the QC team on the methods for the EB and commercial batch analysis at plant
· Responsible for performing the Method validation and method transfer activities of HPLC by preparing the protocols and reports through LIMS.
· Performed Calibration of Instruments like HPLC, GC, UV, IR, Halogen moisture, Analytical Balance and Polari meter by following respective SOPs.
· Responsible for analysis such as Moisture content, LOD, pH Analysis, PSD Analysis, IR, and Volumetric analysis.
· Performed the Daily Calibrations of instruments like Analytical balance, pH Meter, Halogen moisture analyser and KF Standardization.
MSc with 3-8 years of experience
General activities
· Responsible to ensure GMP compliance for all GMP relevant analytical activity.
· Responsible for the Calibrations and Preventive maintenance of HPLC systems as per the given schedule without any deviation by coordinating with the service engineers.
· Responsible for trouble shooting of HPLC Systems in the absence of service persons.
· To perform the instrument calibrations as per master schedule