- As an experienced Computer Systems Validation professional, I have over 13 years of experience in the field, working on building 21 CFR part 11 compliant process equipment software, manufacturing software, Quality Control (QC) software, etc. I am trained and certified in GAMP 5: Risk-Based Approach to Compliant GxP Computerized System and have hands-on experience with laboratory equipment validation (Chromeleon, Tiamo, HPLC, etc.) and PLC Validation (Jekson vision (Ree-track system), Lyophilizer, Autoclave …etc.).- I have collaborated with cross-functional teams, including Quality Assurance, IT, Regulatory Affairs, and Operations, to ensure successful validation and compliance of computer systems. I have been responsible for creating and maintaining CSV documentation, including Validation Plans, Protocols, Reports, and Standard Operating Procedures. Additionally, I have continuously improved CSV processes and procedures to align with industry best practices and regulatory requirements.- Throughout my career, I have been involved in participation in regulatory inspections and audits to support computer system validation and compliance. My experience includes work at PwC India Ltd, where I served as a Sr. Associate and Associate, and contributed to projects including the ABS Alkem Bio-equivalence System (IPHS), SAP-LMS (Success Factor), and ERES Qualification Activity. I also qualified approximately 112 QC lab instruments for performing ERES activities and have experience building Biologics CSV.- Prior to my time at PwC, I worked as a Sr. Executive at Intas Pharmaceuticals Ltd., where I established the software validation approach and provided an independent review of project deliverables to ensure they met regulatory expectations and standards. I also played an instrumental role in the development of the ProcessXE (Online EBMR), Track & Trace System, and Chromatography Data System.- My experience in the field also includes time at Cognizant Technology Solutions, where I worked as a Business Analyst on the PDAMEXH 7.2 and eCRF Archival Utility project, and at Sun Pharmaceutical Industries Pvt. Ltd. as an Officer in Corporate Quality. - While at Sun Pharmaceutical Industries Pvt. Ltd., I was responsible for resolving issues as part of the maintenance team, performing Installation (IQ), Operation (OQ), and Performance (PQ) Qualifications of Process, building FDA 21 CFR part 11 compliance of manufacturing equipment, and more.- As a professional, I am committed to staying up-to-date on the latest industry trends and regulatory requirements.