Rashmi Arragunta
Quality Assurance Professional/ Lead Auditor| Quality System Auditing, Quality Management System, Regulatory Compliance
- Role
- Quality Assurance Iii - Regulatory Compliance at AGC Biologics
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Rashmi Arragunta
RAQA professional with 5+ years of quality and regulatory compliance experience in med tech industry. I am a certified Lead Auditor (ISO 13485:2016). I come with deep knowledge and understanding on quality management system, QSR 21 CFR part 820, GMP requirements including international MDSAP (Australia, Brazil, Canada, Japan and US) and EU country regulations/ requirements.Past Experiences/ Skills:Worked in areas but not limited to Labeling, regulatory submissions of pharmaceutical drugs to FDA, supplier quality management, Design QA specialist for SaMD, validation/verification activities, eDMS, Change Control, CAPA, Internal quality auditing.
Experience
Quality Assurance Iii - Regulatory Compliance
Apr 2025 — Present · Bothell, WA, US
Education
Northeastern University
Masters of Science in Project Management , Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2017 — 2019
Principal K.M. Kundanani College of Pharmacy, Jote Joy Building, Rambhau Salgaonkar Marg ,Cuffe Parade, Mumbai - 400 018.
Bachelors Of Pharmacy
2013 — 2017
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