• To manage the Testing, Validation and Software Quality Assurance team.• Preparation of Validation plan and Validation summary report. Provided correct and complete documented evidence as needed by ISPE GAMP.• To conduct/train internal quality audits. Track NC’s to closure.• To successfully implement LSS programs and achieved results.• To build the training department from ground up and successfully maintained the department. • To be part of process definition team and monitor/implement continuous improvement programs.• To successful achieving CMMI Lev 3 assessment for the organization.• Participate in product reviews and product roadmap activities• Participate and submit periodic reports to decision makers on SQA, testing and validation activities• Plan and track the Internal Quality Audits and Internal assessments for software projects• Monitor process audits across functions in the organization• Worked closely with the overseas Vendor, testing the incremental builds as the functionalities were created in the application in Development, provided inputs, logged defect, retested the fixes and comprehensively validated the application to Production.• Review all protocols and SOP's, requirement docs, project estimates, test cases, and scripts from user requirement and design documents. Review/Validate Computer Systems in compliance 21 part 11, GAMP and GxP FDA Regulations.• Manage relationships with developers, business analysts, and user representatives in application design and document reviews.• Involved in user testing/validating the system upgrade the included 21CFR Part 11 activities in the GMP system. The Change Request includes multiple defects fixes, updated release management system, and multiple users requested enhancements needed to be implemented on a validated computerized system for GxP-regulated environment.

• To manage the Testing, Validation and Software Quality Assurance team.• Worked closely with the overseas Vendor, testing the incremental builds as the functionalities were created in the application in Development, provided inputs, logged defect, retested the fixes and comprehensively validate the application to Production.• To successfully implement LSS programs and achieved results.• To build the training department from ground up and successfully maintained the department. • To be part of process definition team and monitor/implement continuous improvement programs.• To successful achieving CMMI Lev 3 assessment for the organization.• Participate in product reviews and product roadmap activities• Participate and submit periodic reports to decision makers on SQA, testing and validation activities• Implement the metrics system across the organization and identify the new metrics for different process areas.• Plan and track the Internal Quality Audits and Internal assessments for software projects• Monitor process audits across functions in the organization• Conduct process gap analysis• Conducting process training for all other departments • Timely delivery of SQA reports and deliverables as per the project and QAD plans• Review all protocols and SOP's, requirement docs, project estimates, test cases, and scripts from user requirement and design documents. Review/Validate Computer Systems in compliance 21 part 11, GAMP and GxP FDA Regulations.• Manage relationships with developers, business analysts, and user representatives in application design and document reviews.• Involved in user testing/validating the system upgrade the included 21CFR Part 11 activities in the GMP system. The Change Request includes multiple defects fixes, updated release management system, and multiple users requested enhancements needed to be implemented on a validated computerized system for GxP-regulated environment.