Sharmila Senthil Kumar

Background

About Sharmila Senthil Kumar

Having experience of 7.8 years in the pharma industry as a QC analyst. Better knowledge of all principle pharmaceutical technology and analytical processes and concepts. • Performing routine testing, releasing of API, Finished products (Tablets, Syrup, Suspension, Injection, Infusion, Topical solution, Eye drops etc,), Medical devices, Cosmetic and Condoms. • Detailed knowledge of test methods like Chromatography, Titrations and Dissolution, Sterility, MLT and Antibiotic assays. • Performing calibration, maintenance and routine sample analysis of the laboratory equipment like pHmeter, UV spectrophotometer, FTIR, Polarimeter, Dissolution unit, Disintegration Test Apparatus, KF titration, HPLC, Atomic Absorption. • Performing assay (by UV, Titration, HPLC and Fluorimetry), Dissolution, Uniformity of content, Impurity, Disintegration, Antibiotic Assays, Sterility Test, MLT, GPT, and Culture Maintenance. • Performing Enzyme activity assay, Phenotypic Characterizations and genotypic characterization for Cell bank, ELISA, HCP, HCDNA, Western Blot, SDS PAGE, Sterility Test for inprocess sample and finished products, culture maintenance, GPT, Biochemical Test, and Gram Staining. • Maintenance of water system by sampling & testing (Chemical, microbial analysis, TOC and BET-Gel clot Method) • Accompanied in collecting & analyzing data to identify root cause in failure investigation and in recommending CAPA • Active participation in method validation (Sterility Method Validation & BET AMV), instrument qualification and stability study, Preparation of method validation protocols through R&D projects, method preparation, SOP preparation • Analyze the data, identify problem and perform root cause analysis by different suitable. • Having experience in documentation, deviation, CAPA, CR, OOS, OOT ( SOP, STP, SPC, COA) preparation.