Devanshi Doshi
Quality Professional | CGT | Clinical Development
- Role
- Gmp Qc Manager, Cell Therapy at Orgenesis Inc
- Location
- Natick, MA, US
- LinkedIn followers
- 500 followers
About Devanshi Doshi
A biotechnology professional specializing in data review, regulatory documentation…
Experience
Gmp Qc Manager, Cell Therapy
Jul 2023 — Present · Natick, MA, US
Performed in-depth data reviews to ensure data integrity and FDA/cGMP compliance supporting manufacturing of CGT in decentralized Point-of-Care center; authored and approved SOPs, protocols, test methods, specifications, and reports for development, qualification, validation, and outsourced testing. • Ensured compliance with FDA, cGMP, GxPs, and global policies by monitoring all QC processes and aligning with Orgenesis QMS standards.• Implemented eQMS to manage training, deviations, OOS investigations, CAPA-driven changes, and quality system oversight; developed digital systems for traceable QC data, sample, and material tracking.• Oversaw analytical method transfers and GMP standardization across sites; conducted risk assessments, managed vendor coordination, and led structured QC analyst training programs to ensure technical competency.• Led document control operations and maintained eDMS systems to support controlled documents accuracy, traceability and audit readiness.
Education
Florida Institute of Technology
Master’s Degree, Biotechnology
2015 — 2016
Gujarat Technological University (GTU)
Bachelor’s Degree, Biotechnology
2010 — 2014
Skills
- Sop
- Life Sciences
- Epa
- Laboratory Skills
- Pcr
- Western Blotting
- Microsoft Excel
- Gel Electrophoresis
- Spectrophotometry
- Quality Control
- Hplc
- Gmp
- Chromatography
- Cell Biology
- Immunofluorescence
- Dna Extraction
- Microsoft Office
- Glps
- Microbiology
- Immunology
- Data Analysis
- Sds-Page
- Research
- Rt-Pcr
- Environmental Compliance
- Mass Spectrometry
- Microsoft Word
- Protein Expression
- Hazardous Materials Management
- Technical Writing
- Food Quality
- Elisa
- Quality Assurance
- Microscopy
- Qaqc
- Cell Culture
- Bioinformatics
- Southern Blot
- Confocal Microscopy
- Fermentation Technology
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