Responsible for New Product development, Commercialization & Technology Transfer of OSD, Parenteral, Dry Powder Inhalers & Liquid dosage forms.Responsible to Technology Transfer of products to all TPMs.

Approval & reporting of new raw materials received / changed source.Formulation preparation for new dosage forms as per the guidelines GMP, cGMP, ICH & FDA & assure the stability, efficacy & safety of the formulation.Analytical method validation development & of new products.Performing & preparing report of long term, accelerated & stress condition stability studies for the formulations developed.To review costing of new developed products.Preparation of process validation… Show more Approval & reporting of new raw materials received / changed source.Formulation preparation for new dosage forms as per the guidelines GMP, cGMP, ICH & FDA & assure the stability, efficacy & safety of the formulation.Analytical method validation development & of new products.Performing & preparing report of long term, accelerated & stress condition stability studies for the formulations developed.To review costing of new developed products.Preparation of process validation protocol, report & performing validation.Preparation & controlling of batch manufacturing & batch packaging document of new products.To monitor the 1st three commercial batches manufacturing, compression/filling, packaging & assure the manufacturing as per the B.M.R.To review & update the existing formulation.To review the artworks of new products.To prepare the DOSSIER as per the CTD & ACTD formats.To resolve queries regarding the CTD & ACTD DOSSIERS. Show less

Responsible for toll manufacturing related all activities of different dosage forms.To check & assure the inventory of raw material & packaging material required as per the forecast received by the planning.To assure the testing & release of raw materials & packaging materials received.To perform the trial batch manufacturing & assure the stability studies.To assure on time manufacturing of products.To assure the compliance of cGMP & B.M.R during the manufacturing.To… Show more Responsible for toll manufacturing related all activities of different dosage forms.To check & assure the inventory of raw material & packaging material required as per the forecast received by the planning.To assure the testing & release of raw materials & packaging materials received.To perform the trial batch manufacturing & assure the stability studies.To assure on time manufacturing of products.To assure the compliance of cGMP & B.M.R during the manufacturing.To assure the proper storage of raw materials, packaging materials, finished products. Show less

Sampling, testing, data recording & reporting of raw material,in process, finished product samples.Testing of all dosage forms i.e. tablets, capsules, oral liquids, dry powder injections, liquid injections, inhalers, ointment, creams.Calibration of balance, pH meter, karlfischer.Instrumentation:UV (SHIMADZU 1601)HPLC (SHIMADZU LC10, LC20A, LC2010)GAS CHROMATOGRAPHY (SHIMADZU 2014)

Worked as Quality Assurance Inspector in tablet granulation, tablet compression, oral liquid, capsules, sterile area (dry powders & liquid injections) sections.Issue line clearance before dispensing, manufacturing, compression/filling, packing.Sterile area monitoring before manufacturing.To check the batch record & assure the compliance during manufacturing & after batch completion.To check & assure the cGMP compliance during manufacturing.To check & assure manufacturing as… Show more Worked as Quality Assurance Inspector in tablet granulation, tablet compression, oral liquid, capsules, sterile area (dry powders & liquid injections) sections.Issue line clearance before dispensing, manufacturing, compression/filling, packing.Sterile area monitoring before manufacturing.To check the batch record & assure the compliance during manufacturing & after batch completion.To check & assure the cGMP compliance during manufacturing.To check & assure manufacturing as per the B.M.R.To perform the in process checks during manufacturing, compression, filling, packing.To prepare deviation document if found. Show less