As a Lead Consultant with 13 years of experience in Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), Quality Management Systems (QMS), and lab informatics, I have a proven track record of supporting data-driven systems across healthcare, pharmaceutical, industrial, and technology sectors. My expertise lies in the development and implementation of robust solutions, including LIMS, Veeva Vault, and Salesforce, along with process automation tailored for the healthcare and life sciences industries. With a strong foundation in software design, programming, validation, testing, and project management, I have successfully led numerous projects focused on enhancing system capabilities, ensuring compliance with Good Automation (GAMP) guidelines, and delivering comprehensive training to business users. My work has consistently focused on leveraging data analytics and machine learning use cases to drive informed decision-making and improve operational efficiencies.• Trained and certified on following Guidelines and Regulations: o ICH GCP o ISPE GAMP5 o 21 CFR Part 11 o Annexure 11 o ALCOA o FMEA Risk Assessment • Domains served: o Clinical Research o Pharmacovigilance o Pharmaceutical/Medical Device product defect and Issue Management • Application worked on (but not limited to): o LIMS, ELN (Labware, Sample Manager, Biovia, Labvantage) o QMS (Trackwise, veeva), RIM o DMS (Documentum, SharePoint, Alfresco) o Valgenisis o Salesforce o HPALM o JIRA o CTMS o EQMS o Sharepoint o ServiceNow