Pradip Kumar Rout Email & Phone Number

India

Bangalore, Karnataka, India

Bangalore, Karnataka, India

• Literature survey for analytical method development from different official book and internet.• Method validation as per ICH Guideline & USP General chapter 1225 .Assay, RS, Dissolution and Identification.• Validation performs use e Novel software. • Checking and review pre validation study.• Preparation of method development summary report.• Preparation of OOS, deviation and Incident report.• Preparation and review as per validation protocol, ODS and Report.• ANDA supporting analytical filing document handled different regulatory market like UK, EU.• Carry out of all analytical work according to GLP and the regulatory specification.• Active Pharmaceutical Ingredient (API) analysis to verify supplier claim according COA, DMF specification and monograph specification mentioned in different official books.• Checking and review Comparative dissolution profile & calculating F1&F2.Solid oral dosage and Suspension of different novel drug delivery system.

Chennai Area, India

• Literature survey for analytical method development from different official book and internet.• Method validation as per ICH & USP.Assay, Dissolution, RS.• Force degradation Study.• Daily planning for analysis of regular and stability sample, coordination with R&D-formulation.• Carry out of all analytical work according to GLP and the regulatory specification.• Performance of impurityprofile according to regulatory guideline and product requirement.• Complete analysis of solid and liquid dosage form for both trial and stability batch with final reporting.• Active Pharmaceutical Ingredient (API) analysis to verify supplier claim according COA, DMF specification and monograph specification mentioned in different official books.• Column performance test and report preparation. • Working standard preparation and proper storage and labeling.• Comparative dissolution profile & calculating F1&F2.Tablet, Liquid and Dry syrup and different novel drug delivery system. • Perform Calibration of instruments HPLC, UV, IR and dissolution apparatus USP-1 & 2.• Analytical technology transfer to QC.• Preparation ofCOA,STP and FPS• Work experience to handle different regulatory market like UK, EU

Hosur Area, India

• Ensuring cleanliness of the work place and of the laboratory as per GLP.• On time testing of input materials, in-process samples, active pharmaceutical ingredients by Instrumental methods.• Comparison of test results against specifications for release or rejection of materials and products.• Calibration of instruments as per the schedule.• Preparation, maintenance and destruction of working standards.• Trouble Shooting of UV, IR and other major Instruments.• Upkeep of samples under analysis and reserve samples.• Destruction of time expired samples.• Upkeep of completed reports.• Up keep of all usage logs.• To carryout the laboratory investigation in case of any out of specification results.