Responsible for Sampling and Analysis of Raw materials for solubility, LOD, Sulphated ash, water content, Identification by IR / UV , Specific optical rotation, Assay by HPLC or Auto titrator, Related substances by HPLC,
Residual solvents by GC
Responsible for Analysis of Finished products for Average weight, Friability, DT, Hardness, Dissolution, Uniformity of dosage units by
Content uniformity, Assay , RS as per Spec & STP
Qualification of In-house working standards against USP , EP Reference standards
Responsible for Calibration of HPLC, GC, Dissolution apparatus, FTIR, UV-Visible spectrophotometer, KF autotitrator, Potentio meter,
Polarimeter, M.R.Apparatus, Tapped density apparatus, Analytical balances.
Analytical data review for all Raw materials, packing materials, In-process and Finished products
Initiation and closing of Change control, Lab Incidents, OOS, and Deviations.
Preparation and review of standard operating procedures
Preparation and review of Spec & STPs
Timely reporting the quality issues and status to Manager-QC