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Pratik
pratikmodi82@gmail.com
941-807-2851
Hoffman Estates, IL 60067
MS, MSC, Senior Manager, CSV, Software Quality Assurance
17 years experience W2
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Summary

GxP Validation and IT Quality Compliance leader seeking to leverage 16+ years of experience in Computer System Validation (CSV), Software Quality Assurance (SQA), Project / Program Management, and Regulatory Compliance within Pharmaceutical, Biotech and Medical device companies including Baxter International, AbbVie, Abbott Laboratories, Bristol-Myers Squibb, and Natera. Specialized in regulations and standards FDA 21 CFR Parts 11, 210, 211, 820, HIPAA, PMDA, EU Annex 11, CAP / CLIA, IVDR, ICH, ISO 13485, GAMP5.

Experience
Education
Master's in Cell/Cellular and Molecular Biology
LIU Brooklyn, 2006 - 2008
Master's in Microbiology
Sardar Patel University, 2004 - 2006
Bachelor's in Microbiology
Sardar Patel University, 2001 - 2004
Certifications
Regulatory Education for Industry (REdI) Annual Conference 2022 - CBER Track
FDA U.S. Food and Drug Administration, 2022
Skills
Quality Assurance
2024
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Artificial Intelligence
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Audit
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Auditing
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Automated Testing
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AWS
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Business Analysis
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Cancer
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Compliance
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CRM
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CTMS
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Devops
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Documentum
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ERP
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FMEA
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Gap Analysis
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Gitlab
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Good Manufacturing Practices
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GSAP
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HP Loadrunner
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HP QC
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HP QTP
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IFRS
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Internal Audit
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IT Audit
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J.D. Edwards
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JIRA
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LiveLink
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Manual Testing
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Medical Devices
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Mercury Winrunner
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MES
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Microsoft Excel
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MS Azure
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MS Visio
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Pharmaceutical
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PQ
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Program Management
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Program Management
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Project Management
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Regulatory Compliance
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Requirements Gathering
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Risk Management
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SAP
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SAP SOP
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SDLC
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Software
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System Testing
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Test Planning
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Training
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Vendor Management
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Publications
Effect on proliferation and differentiation of a polyphenol desoxybenzoin on HO-1 human melanoma cells
, 2009