Presently handling a position as Technical Lead and responsible for Accountability of Development / Method Validation:Major role in Leading Team of Analysts responsible for development and optimization of In-vitro release test and In-vitro permeation test analytical methods for Topical Dosage forms.Ensuring Validating analytical methods of In-vitro release test and In-vitro permeation test as per sponsor requirements and as per Bio-analytical and FDA guidelines.Checking of data accuracy and integrity, data collection and report / protocol preparation.Software Tools:Preparing SDLC documents and implementation of software tools to meet client's and regulatory requirements. Monitoring and Performing Computer System Validations as per 21 CFR compliance and GxP FDA Regulations.Ensuring proper and sufficient testing before deployment as per organizational needs.Commitment to quality:Ensuring activities conducted in the lab are in compliance with established SOP’s, procedures, systems, regulatory guidance without deviating from established procedures and generation of data for IND /NDA filing.SOP and Trainings:Understanding and working as per SOP’s and procedures.Train, Manage & Supervise junior level analysts to perform routine analytical work as per established procedures.Interface with Quality Assurance team and Clients:Working closely with Quality Assurance team and clients for data and reports accuracy, closure of observations and preparation of final reports.Calibration /Maintenance of Instruments:Ensuring IQ/OQ and PQ for the new instruments / equipment’s / software's and timely calibrations. Maintenance of instruments / equipment’s and performing computer system validations as per 21 CFR compliance / GxP FDA Regulations.Routine Procedures and System Checks:Reviewing general documents, logbooks, calibration records required in GLP compliance and report findings to Head of Department.

Worked as Research Scientist in Speciality Product Division (Derma) and guiding Analytical activities in ANDA product development of US and European market for Topical Formulations.Managing resources and applying knowledge of Topical dosage forms testing to guide for completion of Method development, Method validation and Documentation along with the team.Timelines has been maintained on assigned projects.Initiate,execute,analyse,report and evaluate on topical drug product and analytical methods.Supporting Formulation R&D to deliver Generic topical dosage forms.Accountable to group leader for the various US ANDA products and Europe Dossiers.Ensuring execution of Method development, Method Validation, protocols, summary reports and calibration of Various Analytical Instruments.Ensuring delivery of robust, reliable validated test methods, specifications and regulatory documents.Responsible for IQ/OQ and PQ for the new Instruments/Equipments.Handling, training for colleagues through various Guidelines and SOP trainings and taking seminars on topics of relevance.Ensuring that the group and the lab complies with cGMP, SOP and ICH guidelines.

Performing In-Vitro Permeation Studies by Franz’s diffusion Technique.Performing Assay, Content Uniformity, Residue Analysis of drug samples of FR&D trails and interpreting the results by using HPLC and UV-Spectrophotometer.Performing Method Transfer Activity from R&D to Manufacturing Site.Routine analysis of samples in support of FR&D trials in the Product development.Estimation of Viscosity by Brookfield Viscometer.Evaluation of the Stability data of drug products in different storage conditions as per stability schedule.Analysis of compatibility study samples, in process and finished products under GLP.Performing analysis by following cGMP guidelines

Performing In-Vitro Skin Permeation Studies by Franz’s diffusion Technique.Performing Physical Characterization of Transdermal Patches (Shear,Tack and Peel).Performing Dissolution, Assay, Content Uniformity, Residue Analysis of drug samples of FR&D trails and interpreting the results by using HPLC and UV-Spectrophotometer.Routine analysis of samples in support of FR&D trials in the Product development. Estimation of Water content by KF.Evaluation of the Stability data of drug products in different storage conditions as per stability schedule.Analysis of compatibility study samples, in process and finished products under GLP.Performing analysis by following cGMP guidelines

Performing Blend Uniformity, In-Process Quality Control tests for Solid Oral Dosage Forms.Performing Quality Control Tests (Dissolution, Assay, Content Uniformity) of Finished Solid Oral Dosage Forms.Evaluation of the Stability data of drug products in different storage conditions by analyzing the drug products as per stability scheduleEnsure that equipment/instruments were calibrated and maintained and that laboratory records/documentation complies with cGMP guidelines.