Siddharth Katkar Email & Phone Number

Quality Control Officer with 1.8 years of experience in the biopharmaceutical industry and a Master’s in Biotechnology. Skilled in analytical testing and regulatory compliance, I am committed to ensuring product quality and safety. Eager to leverage my expertise to contribute to quality initiatives in a dynamic organization.

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  Quality Control Officer

  Serum Institute Of India Pvt. Ltd.

  Feb 2023 - Nov 2024 - Pune, Maharashtra, India

  Quality Control testing of concentrated In-Process samples, final formulated bulks and final drugproducts with compliance to Good Laboratory Practices (GLP).�Estimation of Invitro potency of HB component in Hexavalent (DTPHBIPVHib) Vaccine (Stability, Blend,Final lot, Labelled lot, Ready to fill blend, engineering batches).�Stability study planning & execution for Hexavalent vaccine (Real time, accelerated, stress studies)(Stability sample charging, withdrawal & sample distribution to respective department).�Analytical data compilation, Trend analysis, preparation of summary, graph, COA with compliance toGood documentation practice (GDP) and submission.�Analytical data compilation, preparation of summary & COA, submit to CDL.�Analytical method development for estimation of invitro potency of HB component using ADALTISEIAgen HBsAg Kit.�N terminal sequencing for HBsAg Aqu. Bulk sample using Protein peptide sequencer.�Lot Release Testing such as pH, Osmolality, Extractable Volume, Physical inspection.�Preparation of SOP & MTR.�Physical verification (Screening) of retention sample.�Maintenance & issuance of chemicals, antibody, standard, kits for testing.�Daily, weekly, monthly maintenance of Vitros 3600 machine.�Execution of scheduled calibrations & maintenance of lab equipment’s and instruments (Vitros 3600,pH meter, Osmometer, Micro weighing balance) in coordination with vendors.�Data Analysis: Ability to analyze and interpret data generated from experiments using software toolslike:�Microsoft Excel for basic data analysis�Statistical software packages (e.g., COMBISTAT) for advanced statistical analysis for potencyassays.�Sukra software.�Gen 5 ELISA software.�Quality Management System (QMS) activities.�eDMS, LIMS, eLMS, SAP.