Devendra Kushwaha

• Industrial training in Production (Tablet, Capsule, Ointment & Powder department) Packing & Quality Control department

Analytical Method Development and Validation

Excellent skills on

HPLC, UV, IR, KF, Dissolution test Apparatus(USP-I,II,III,IV), DSC, Hot stage microscope, Preparative HPLC.

• Nitrosamine Impurity Assessment and Method Development
• The work includes Analytical method development and validation for oral solid dosage form like Tablets and capsules (hard gelatin and soft gelatin) of dissolution, Assay, RS, CU, BU, water content etc
• The work includes Analytical support to formulation development for scale up and Exhibit Batch analysis and stability studies
• The work includes Analytical method verification and qualification of API/working standard
• And Prepare verification reports and COA
• The work includes stability analysis, routine analysis and analytical support during method transfer
• To ensure maintain records of inward outward of impurity, working standard, HPLC column and maintain the lab requirements or reagents and special chemical
• Conversant with Calibration & Maintenance of lab equipments like HPLC, UV, IR, Dissolution test Apparatus(USP-I,II,III), Analytical weighing balance etc
• Experience in technical documentation like validation protocol, Method development reports, COA & report preparation etc
• Good knowledge of cGMP / GLP, ICH guidelines