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 OfficerSerum Institute Of India Pvt. Ltd. Feb 2023 - Nov 2024Pune, Maharashtra, IndiaQuality 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.
Siddharth Katkar Education Details
Frequently Asked Questions about Siddharth Katkar
What is Siddharth Katkar's role at the current company?
Siddharth Katkar's current role is Quality control officer at Serum Institute of India PVT ltd Pune.
What schools did Siddharth Katkar attend?
Siddharth Katkar attended K L E Society's Jawaharlal Nehru Medical College, Dmsm's B K College Of Arts, Scie & Comm College, Belgaum.
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Siddharth Sandeep Katkar
Working With Top Investment Bank Ubs As Role Gcs Platform Specialist | Ex- AccentureMumbai1chembondwater.com -
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SIDDHARTH KATKAR
Pune
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