Suniti Das

Background

About Suniti Das

I am a dedicated Validation Engineer with a strong background in the life sciences industry, currently employed at USDM LifeSciences in the United States. My professional journey has equipped me with a comprehensive understanding of the critical role validation plays in ensuring the safety, quality, and compliance of pharmaceutical, biotech, and medical device products. With a keen eye for detail and a commitment to adhering to regulatory standards, I excel in developing and executing validation protocols, including IQ, OQ, PQ, and process validation, to guarantee the integrity of manufacturing and quality control processes. I am well-versed in industry standards such as GxP, cGMP, 21 CFR Part 11, and ISO standards. My role at USDM LifeSciences has allowed me to collaborate with cross-functional teams, regulatory agencies, and clients to deliver comprehensive validation solutions that mitigate risks, enhance operational efficiency, and meet regulatory requirements. I am proficient in leveraging cutting-edge validation methodologies, software tools, and analytical techniques to support the development, manufacturing, and distribution of life sciences products. I am passionate about staying updated with industry trends, regulatory changes, and technological advancements to continuously improve the validation process and contribute to the overall success of the organization. My dedication to maintaining the highest quality standards and ensuring patient safety is unwavering.