· Diversified experience across Application Development & Application Maintenance predominantly in End to End Computer System Validation (CSV), Quality Assurance and Control, Regulatory Compliance, Regulatory Submissions, Regulatory Consulting, Process Consulting, Data Migration and verification.

· Expertise in Quality Systems Auditing (GxP Inspection readiness, SOx and Internal Control Audits) for Life Sciences Industry

· Expert in designing validation strategies and procedures for large SAP ERP deployments and maintenance activities

· Proficient in ensuring Quality Assurance for computerized systems across pharmaceutical development lifecycle (Clinical, Supply Chain, PV etc.) for big pharma companies

· Strong domain knowledge in Procure to Pay (P2P),Order To Cash (OTC) and Manufacture to Demand (M2D) business processes in SAP ERP

· In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls

· Certified Scrum Master (CSM) in Agile Methodology