Analytical method development

Analytical method development and Stability studies.Experience on Solid oral dosage form (immediate and extended release), Suspension.Performing routine Assay, Dissolution and RS of initial and stability samples along with compilation and evaluation of the trend of data.Preparing method Development Report and Preparing Standard Test Procedure for API or Finished Product.Awareness of compliance wrt GMP and GLP.Timely Pharmacopoeial review to ensure compliance with regulatory requirement.

Analytical method development and Stability studies.Experience on Solid oral dosage form (immediate and extended release), semisolid dosage form, injectables and NCE molecules.Knowledge of method development and Validation for Assay, RS and Dissolution methods for multi strength solid oral dosage form.Knowledge of method development for genotoxic impurities quantitation.Expertise in method development for double component dosage form and micro dose dosage form (Peptides and Hormones).Performing routine Assay, Dissolution and RS of initial and stability samples along with compilation and evaluation of the trend of data.Method workability of methods from API Suppliers.Experience of route cause analysis, OOS & OOT investigation.COA, Stability data comparison and Protocol preparation.Support to validation activities wrt Forced degradation report and Method equivalencies.Management of Working Standard, Analytical Standard and Reference Standard.Preparing method Development Report and Preparing Standard Test Procedure for API or Finished Product.Awareness of compliance wrt GMP and GLP.Timely Pharmacopoeial review to ensure compliance with regulatory requirements.

Worked on Solid oral dosage form.Performing Calibration of HPLC, Dissolution Apparatus, UV, FTIR, Balance and KF-titrator.Performing Assay, Dissolution and RS of finished products.Experience of route cause analysis, OOS & OOT investigation.Awareness of compliance GMP and GLP.Management of Working Standard, Analytical Standard and Reference Standard.

Worked on inhaler dosage form, suspension and solid oral dosage form.Performing Calibration of UV, FTIR, Balance, KF-titrator and Particle Size analyzer.Worked on instrument section department.Experience of route cause analysis, OOS & OOT investigation.Awareness of compliance wrt GMP and GLP.

Worked on Solid oral dosage form.Worked on instrument section department.Experience of route cause analysis, OOS & OOT investigation.Awareness of compliance GMP and GLP.