Anmol V.
Quality Specialist at Merck with 6 years of experience
- Role
- Quality Specialist at Merck
- Location
- Omaha, NE, US
- LinkedIn followers
- 500 followers
About Anmol V.
I’m a Quality Assurance Specialist with 6+ years of experience ensuring regulatory compliance, product reliability, and operational excellence across medical devices, pharma, and software systems. Currently working at Merck Animal Health, I specialize in maintaining the highest quality standards under FDA 21 CFR Part 820, ISO 13485, and GxP frameworks.My passion lies in bridging quality systems with emerging technologies — leveraging AI, data integrity, and process automation to simplify compliance and drive continuous improvement. I’ve successfully supported projects involving validation (IQ, OQ, PQ), CAPA investigations, supplier quality, and risk management, ensuring products meet both regulatory and business goals.Now, I’m exploring remote and hybrid opportunities with forward-thinking organizations — from AI startups to global leaders — where I can contribute my experience in quality systems, validation, and compliance, while growing toward quality automation, data governance, and digital transformation initiatives. Expertise: Quality Assurance | CAPA | Risk Assessment | Validation (IQ/OQ/PQ)| FDA & ISO Compliance | Supplier Quality | GxP | Data Integrity Industries: Medical Devices | Pharmaceuticals | Software (SaMD)| AI & Regulated Tech Vision: To integrate AI and smart quality systems that make compliance faster, smarter, and globally scalable.
Experience
Quality Specialist
Jan 2025 — Present
Education
Wichita State University
MEM
Malla Reddy Engineering College
Bachelor of Technology
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