Performed assessment of Nitrosamine impurities, NDSRIs and successfully developed and validatedanalytical method for Nitrosamines by LCMS for topical and solid oral products.Developed and validated analytical methods for semisolid dosage forms for various tests like Relatedsubstances, Assay, Preservative content and characterizations tests.Engaged in technology transfer for LCMS, HPLC, PSD techniques with respect to finished products.Involved in Attending & resolving FDA… Show more Performed assessment of Nitrosamine impurities, NDSRIs and successfully developed and validatedanalytical method for Nitrosamines by LCMS for topical and solid oral products.Developed and validated analytical methods for semisolid dosage forms for various tests like Relatedsubstances, Assay, Preservative content and characterizations tests.Engaged in technology transfer for LCMS, HPLC, PSD techniques with respect to finished products.Involved in Attending & resolving FDA queries for markets across US, Europe, Brazil.Involved in plant investigations for OOS and critical issues, Direct/Indirect Technical Support acrossplant locations.Guided formulation team for selection of suitable excipient during development of cream formulationDeveloped specific studies such as Force Degradation Study, Method Equivalency as per definedregulatory requirements.Conducted Literature Survey for Analytical Method Development activity for tests such as Assay,Dissolution, Organic Impurities, Preservative for regulatory Market.Prepared Method Development Report, Protocols, Specifications and Standard Test Procedures forvarious analytical procedures.Prepared Standard Operating Procedures for laboratory instruments. Show less

Rendered analytical support in development of hormonal products like Tablets, Capsule, creams, gelsand injections by performing routine analysis, and preformulation study.Performed BCS Studies for orally administered pharmaceutical drugs.Setting up In-house Working, Reference Standard and Impurity Standard while managing procurementand maintenance of USP/ BP/EP Reference Standards.Ensuring all Lab Safety and GLP Practices are maintained within the lab

Conducted testing of developmental batches and stability study batches as per plan.Smartly used Malvern MS 3000 PSD instrument which results in providing accurate and robust data formany compounds.Routine analysis & Stability analysis of dermatological products.Preformulation studies of active ingredients with excipients.

Executed successful method transfer of dissolution test for one of the milestone project.Provided technical inputs for method development.Provided inputs on the current status of the client project to supervisors.Engaged in periodic updation of SOPs related to functional area.Responsible for compliance with customer auditsManaged calibration of analytical instruments like HPLC, Dissolution, UV, pH meter, Analytical Balance,PSD instrument.

Instrumental Analysis Using HPLC, UV, IR, Polarimeter, Potentiometer, Karl Fisher, pH meter, Melting Point Apparatus.Calibration of instruments and maintaining calibration schedule records.Analysis of raw material, in process samples, finished products as per USP, BP, IPPreparation of raw material specifications as per Pharmacopeia and In house standards.Sampling of raw material, in process samples and finished products as per SOP.