Shweta Bhati
Ottawa,ON
Summary
A pharmaceutical quality control professional with a Master’s in Biotechnology and more than 4 years of experience delivering high impact results in research, quality control, and project management. Has proven proficiency in analytical reporting, stakeholder management, and technical documentation.
Overview
1
1
Certification
5
5
years of professional experience
Work History
Quality Control Technician
BWXT Medical Inc.
Ottawa, Ontario
06.2021 - 03.2024
- Collaborated with scientists in CMC group and research and development department to shape strategies around quality control for drug development
- Managed day-to-day activity using Oracle ERP software to streamlined project management, accurate tracking of accounting, procurement, and risk management
- Conducted ionizing radiation research on Mo99/Tc99 and the related impurities
- Developed and implemented a quality control plan for more than 4 drug substance testing protocols, resulting in accurate identification and estimation of substance of interest
- Applied qualitative and quantitative tests on radio-active samples using UV/Vis spectrophotometer, Gamma ray spectrometer, and ICP Mass Spectrometer
- Documented analytical reports, stakeholders' briefings, and presentations to communicate results with economic impact analysis of various products
- Coordinated OOS and deviation investigations, executed CAPA plan to eliminate underlying causes using root cause analysis through fishbone diagrams
- Managed a team of 3 technicians, provided training on cGMP, GCP, and GDP standards for drug substance development, and upskilled on documentation, data analysis, and reporting techniques
- Performed data analysis on MS Excel using Vlookups, pivot tables, and data aggregation functions, calculated relevant KPIs and metrics for performance measurement and evaluation
- Facilitated external audit team and FDA officials with relevant data and documentation to ensure compliance with SOPs, cGMP guidelines, 21 CFR part 11, and ISO standards
- Experienced in understanding approved technical drawings, and schematics for the identification of critical fixtures, and designs improvement for radiation safety
- Leveraged JIRA as a project management tool for planning, tracking, and managing project timelines, activities, and communications
- Executed Installation Qualification, Operational Qualification and Performance Qualification for Gamma Spectrometry, GEX Dosimetry
Topographic Memory influence Stem cells II Summer Intern
University Medical Centre Groningen
Groningen, Groningen
05.2016 - 07.2016
- Fabricated PDMS films with different wrinkle sizes by oxidizing surface using plasma oxygen
- Characterized the wrinkle size and geometry on PDM surfaces using atomic force microscopy
- Cultured and studied Human Mesenchymal Stem Cells (hMSCs) response and morphological differences to different topologies
- Examined morphological differences using confocal laser scanning microscopy and protein labeling, identified preservation of morphological differences in later passages
- Worked and ensured safety and compliance within BSL-2 environment
II Research Assistant
Immunoengineering Laboratory, IIT Bombay
Mumbai, Maharashtra
09.2017 - 09.2019
- Studied the metabolic effect of cytokines on human keratinocytes and cancer cells
- Analyzed signaling pathways stimulated using the MitoCore model
- Applied statistical method and interpreted the results using Tableau
- Conducted immunofluorescent and radiometric assay to study the skin and cancer cell response to cytokines
Education
Regulatory Affairs Graduate Certificate -
Algonquin College
Ottawa, ONMaster of Science Biotechnology -
Indian Institute of Technology Bombay
Skills
- Analytical skills: UV-Vis Spectroscopy, NMR, ICP-MS, FTIR, PSA, TGA, Chromatography, Gamma and Alpha Spectroscopy, AFM, protein assay, RT-qPCR, Immunoprecipitation, Western Bolt
- Cell culture skills: Human Mesenchymal Stem Cells, Human Keratinocytes cells, Jurkat cells, and bacterial cells
- Bioinformatics skills: BLAST, PSI-BLAST, CLUSTALW, SWISS-MODEl, PyMol, CFSSP, CDD
- Genetic engineering skills: Plasmid isolation, Polymerase chain reaction, competent cell, preparation by calcium chloride method, Cloning of gene, Transformation of bacteria by electroporation
- Computational skills: Microsoft Office Suite, SQL, Tableau, JIRA
Certification
- WHMIS
- Nuclear Energy Worker
- Confined Space Worker
- OHSA
- Working at Height
Training
- Genetic Engineering
- Biophysics
- Bionanotechnology
- Biomaterials
- Immunology
- Analytical Biochemistry
- Biodesign
- Mathematics and statistics
- Molecular Biology
- Enzymology
- Bioinformatics
- Biomolecular spectroscopy
- C programming language
Languages
English
Full Professional
Timeline
Quality Control Technician
BWXT Medical Inc.
06.2021 - 03.2024
II Research Assistant
Immunoengineering Laboratory, IIT Bombay
09.2017 - 09.2019
Topographic Memory influence Stem cells II Summer Intern
University Medical Centre Groningen
05.2016 - 07.2016
Regulatory Affairs Graduate Certificate -
Algonquin College
Master of Science Biotechnology -
Indian Institute of Technology Bombay
- WHMIS
- Nuclear Energy Worker
- Confined Space Worker
- OHSA
- Working at Height
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