Vivek Sheth

Background

About Vivek Sheth

I am a dedicated Quality Associate with a proven background in the pharmaceutical industry, currently focusing on Quality Management System (QMS) implementation. With hands-on experience in comparator sourcing, clinical trial study design and consultancy, secondary labeling, and packaging, I bring a thorough understanding of pharmaceutical logistics, including temperature-controlled and non-temperature-controlled shipments of both pharmaceuticals and ancillaries. Throughout my career, I have cultivated a strong expertise in regulatory compliance, including CFR Part 11, 210 & 211, EU Annex 11, and GxP standards (Good Distribution Practice, Good Documentation Practice, and more). I am passionate about advancing into Quality Assurance roles, particularly within pharmaceutical, biotechnological, and clinical research organizations (CROs). As a committed professional in the field, I am enthusiastic about opportunities where I can leverage my experience to uphold the highest standards of quality, compliance, and safety, ensuring that all processes align seamlessly with industry regulations. My objective is to contribute to the industry's advancements by applying my QMS insights and expanding my skill set in QA.