Shriya Sharma
QA Validation Leader | GMP Compliance, Validation & Audit Readiness
- Role
- Senior Quality Assurance Validation Specialist- Iv at Pfizer
- Location
- Burlington, MA, US
- LinkedIn followers
- 500 followers
About Shriya Sharma
Highly driven Quality Assurance professional with over a decade of experience in process validation, data integrity, and quality systems compliance within the pharmaceutical and biopharma industry.My expertise spans validation lifecycle management (PPQ, CPV), data integrity (ALCOA+, Part 11, Annex 11), and global regulatory readiness (FDA, EMA, MHRA, ICH). I have successfully led cross-functional teams through inspection readiness, process validation strategies, and data governance programs—ensuring compliance while supporting operational efficiency and product innovation.What sets me apart is my ability to bridge technical depth with leadership, translating complex regulatory requirements into practical strategies that drive business growth. I thrive in mid-size and fast-growing companies where I can shape quality culture, mentor teams, and ensure right-first-time compliance.
Experience
Senior Quality Assurance Validation Specialist- Iv
Jul 2019 — Present
Education
Wright State University
Masters, Pharmacology and Toxicology
2015 — 2017
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