Vraj Patel
Quality Systems Specialist | QA | Cell and Gene Therapy | Validation | Biologics | Regulatory Affairs |
- Role
- Senior Specialist - Quality Systems at ProBio
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
About Vraj Patel
Driven by a strong commitment to quality and compliance in biologics manufacturing, I specialize in Quality Systems, audit readiness, and regulatory compliance within cGMP environments. As an ASQ Certified Quality Auditor (CQA), I bring a risk-based and systems-oriented mindset to deviation management, change control, CAPA, and process oversight. My experience spans supporting biologics manufacturing operations, strengthening QMS frameworks, leading audit readiness initiatives, and ensuring alignment with global regulatory standards, including 21 CFR 210/211, 820, ISO 9001, and ICH guidelines. I am particularly passionate about building resilient quality systems that are inspection-ready by design, not by reaction. I believe quality is not just a function; it is a culture that drives long-term operational integrity and patient safety. Let’s connect if you’re focused on advancing quality excellence in pharmaceutical and biologics manufacturing.
Experience
Senior Specialist - Quality Systems
Jul 2025 — Present · Pennington, NJ, US
Education
Northeastern University
Master's degree, Regulatory Affairs
University of Mumbai
Bachelor of Pharmacy - BPharm
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