Kewal S.
About Kewal S.
Kewal S. is a Validation Engineer with extensive experience in the pharmaceutical industry, currently working at Kite Pharma in Santa Monica, California. He has held various positions at companies such as Takeda, NeoGenomics Laboratories, and Abbott, and possesses in-depth knowledge of regulatory guidelines and quality assurance processes.
Work at Kite Pharma
Currently, Kewal S. serves as a Validation Engineer at Kite Pharma, a position he has held since 2021. His responsibilities include developing and executing Validation Plans and Qualification Protocols for various systems, including LabWare LIMS and ERP. Kewal's role involves ensuring compliance with industry regulations and standards, contributing to the overall quality assurance processes within the organization.
Work Experience at Ultragenyx Pharmaceutical Inc.
Kewal S. has been employed as a GCP QA Test Engineer at Ultragenyx Pharmaceutical Inc. since 2021. His work focuses on ensuring compliance with Good Clinical Practice (GCP) guidelines. Kewal's expertise in quality assurance plays a crucial role in maintaining the integrity of clinical trials and related processes within the company.
Previous Employment at Takeda and Other Companies
Before his current roles, Kewal S. worked at Takeda as a Validation Engineer from 2016 to 2017. He also held positions at NeoGenomics Laboratories as a CSV Engineer from 2017 to 2019, and at Abbott as a Validation Engineer from 2019 to 2020. Additionally, he worked at Amneal Pharmaceuticals as a Validation Engineer from 2015 to 2016. His diverse experience in validation engineering spans multiple organizations and industries.
Education and Expertise
Kewal S. studied at Northeastern University, where he achieved a degree in Computer and Information Sciences. He possesses in-depth knowledge of various regulatory guidelines, including ICH Q9, EU Annex 11, GAMP 5, GLP, GCP, GMP, and GDP. Kewal is also experienced in implementing 21 CFR Part 11 and Data Integrity protocols in regulated environments.
Skills in Quality Assurance and Validation
Kewal S. is skilled in using Quality Centre for managing tests and defects. He has experience in writing Standard Operating Procedures and validation policies. His expertise includes participating in cross-functional activities utilizing Corrective Action Preventive Actions (CAPA) and System Compliance Assessment, which are essential for maintaining compliance and quality in regulated industries.