As an assistant manager at Deloitte, I leverage my regulatory expertise and CSV skills to deliver high-quality solutions for clients in the pharma domain. With over four years of work experience, I have successfully validated software equipment, SCADA systems, and lab instruments as per GAMP 5 and 21 CFR Part 11 guidelines, prepared documents and SOPs, and represented projects in internal and external meetings. I have also contributed to the regulatory risk assessment and impact analysis of various software systems and processes. Some of the methods and tools I use include AGILE, SAP, HPALM, ServiceNow, JIRA, Trackwise, eLIMS, TIAMO, Chromeleon, IPC, DAS, SCADA, QMS16, and MINITAB16. Prior to joining Deloitte, I was a CSV consultant at Kelly, where I worked on similar projects for different clients. My core competencies include regulatory affairs, clinical research, quality operations, and CSV. My mission is to ensure compliance, safety, and efficiency in the pharma industry. I am passionate about learning new technologies and best practices, and collaborating with diverse teams to achieve shared goals.