Aravind Kashyap B

• Moved to a new project to support a japanese pharmaceutical major. Significant transition from working within a project to an independent ITC consultant role.
• Responsibilities included Change Management, Deviation Management, Project Management, Infrastructure Qualification, SOP revisions, review and approval of CSV deliverables.
• Worked on over 15 COTS/custom application changes. Developed validation strategy based on risk and impact ensuring validated status of changes.
• Worked on implementation of Infrastructure Qualification for the first time. Guided stakeholders on aspects of quality, GxP Compliance and significance of qualification

In addition to module specific deliverables, worked on review of project deliverables - Promotion Forms, Test Summary Reports, Deployment Cutover Report, Validation Summary Report, Data Migration and Load Reports.

• Mentored junior team of 5 members, fostering professional growth and enhancing team productivity Trained new team members on client-specific GDP practices, resulting in first-time-right documentation, reduced rework, and sustained high-quality deliverables
• Led functional team preparation for internal and client audits, aligning documentation with compliance standards and ensuring successful audit outcomes.

• Managed a complex SAP O2C module involving both GxP and Non-GxP workflows, navigating regulatory boundaries to streamline decision-making and ensure compliant process execution.
• Work products included authoring and review of User and Functional Requirement Specification, Design Configuration and Specifications, Test Scripts, Test Runs, Defects and Requirement Traceability Matrix.
• Led the EMEA SIT phase for SAP O2C, authoring and reviewing 600+ test cases and 1500+ test executions within a 3-month deadline — the highest test volume across modules — ensuring compliance and traceability.
• Developed ‘Compliance Nuggets’ — daily infographic slides educating testers on compliance checkpoints, which significantly reduced documentation errors and enhanced test quality during the EMEA rollout.
• GDP Review Tool Testing: GDP tool performs common checks on word documents. Helped my team in testing GDP review tool. Prepared different scenarios to test GDP tool to ensure all checks are covered. Conducted sessions for technical team on usage of GDP Review tool while authoring the documents.

Got trained in Automation Testing and was assigned to CSV skill under Life Sciences Compliance Office.

• Tagged to Japanese pharmaceutical major as a SAP S/4 HANA cloud implementation project. It is a large scale Business Transformation & System Integration program to create a global operating model with standardized processes across geographies and enhance business to continue pursuit of operational excellence.
• Responsibility: Facilitate the implementation of a SAP S/4 HANA v1709 system on Microsoft Azure cloud which complies with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 Guidelines across Global regions (Americas, EMEA, Japan & APAC).
• Started delivery as Internal Compliance POC for Non GxP SAP module - Procure to Pay (P2P).
• Participated in Audit for verification of training records and report submission to client.
• Created monthly Compliance Awareness content for client newsletters, simplifying regulatory concepts through creative visual communication to drive compliance understanding across teams.