Sudar Muthusamy Csm, Safe Practitioner Email & Phone Number

Toronto, Canada Area

Toronto, Canada Area

• Responsible for forecasting test resource needs and financial management • Lead the QA team in Waterfall and Agile – System testing, Integration testing, Regression testing, batch process testing, database testing and risk based testing. • Drive all testing activities including performance and test automation for assigned projects • Communicate the testing status via Dashboards with Daily/Weekly and Monthly metrics • Partnered with customers on User/Business Acceptance… Show more • Responsible for forecasting test resource needs and financial management • Lead the QA team in Waterfall and Agile – System testing, Integration testing, Regression testing, batch process testing, database testing and risk based testing. • Drive all testing activities including performance and test automation for assigned projects • Communicate the testing status via Dashboards with Daily/Weekly and Monthly metrics • Partnered with customers on User/Business Acceptance testing • Key point of contact to respond to internal SOX Audit conducted by KPMG • Key contributor in setting up the Testing Center of Excellence (TCoE) • Develop / review Test Strategy, Test Plan, Summary Report and Defect Report; create / review test scenarios, test cases and test data setup • Review functional and non-functional requirements • Manage, guide and mentor a team of QA leads and analysts in role development, process improvements, continuous integration, etc., Show less

Greater Chicago Area

• Led a team of testers working for the Validation testing of Warehouse Management System (Supply Chain Management). • Managed and guided the team on the testing activities performed. • Acted as SME for the application and assist with the clarifications raised pertaining to requirements, defect related documentation and adherence to the procedures. • Created/Reviewed the test scripts and test logs generated by the team.• Reported the status of day to day testing activities to… Show more • Led a team of testers working for the Validation testing of Warehouse Management System (Supply Chain Management). • Managed and guided the team on the testing activities performed. • Acted as SME for the application and assist with the clarifications raised pertaining to requirements, defect related documentation and adherence to the procedures. • Created/Reviewed the test scripts and test logs generated by the team.• Reported the status of day to day testing activities to the client Test coordinator. • Reported the weekly status to the client QA Manager and also ensures SLAs are met. • Scheduled & facilitated meetings on a daily basis with Subject Matter Experts, Validation Analysts, Software Quality assurance engineers on issue resolution, requirement clarifications, etc., • Generated and reported project metrics • Responsible for planning and estimation of projects. Show less

Greater Los Angeles Area

• Managed end to end Validation activities as Validation Lead for the implementation of SAP ECC 6.0 (FI/CO, SD (SD & IP Vistex), MM, WM, QM, PP modules and EDI interfaces) by providing specialized domain inputs on the validation practices.• Controlled, monitored, tracked and provided guidance on the overall project documentation and configuration management in each phase of SDLC.• Delivered regular validation project status communication to key project stakeholders including senior… Show more • Managed end to end Validation activities as Validation Lead for the implementation of SAP ECC 6.0 (FI/CO, SD (SD & IP Vistex), MM, WM, QM, PP modules and EDI interfaces) by providing specialized domain inputs on the validation practices.• Controlled, monitored, tracked and provided guidance on the overall project documentation and configuration management in each phase of SDLC.• Delivered regular validation project status communication to key project stakeholders including senior management IT, Subject Matter Experts, etc.,• Established a Risk based validation approach (as guided by International Society for Pharmaceutical Engineering (ISPE); Guide for Validation of Automated Systems in Pharmaceutical Manufacture (GAMP4) – published Dec 2001) by conducting Regulatory and Functional Risk Assessment with the Subject Matter Experts of each module, Compliance team and Functional leads. • Defined / Reviewed process and standard operating procedures like Change Management, Software Configuration Management, Security, etc., • Conducted training on the validation process and procedures proficiently to all facets of the client and project team.• Scheduled & Facilitated meetings in a daily and weekly basis with stakeholders• Provided guidance to Validation team• Acted as first level of escalation for any issues.• Defined Validation strategy for the project and created /reviewed validation documentation including the User Requirement Specification (and blueprints for each module), Validation Test Plan, Summary Report, Trace Matrix (and Business Process Master List), IQ, OQ, PQ, Data Migration strategy documents, Functional and Technical specification (for LSMW, User Exits, Development, etc.,), Configuration Guides, Security Design documents, Validation Test Scripts (IQ, OQ, PQ, DMQ, Security), change control management, etc., • Set up process for Deviation Handling and driving Defect calls and conducting walk through sessions. Show less

Chennai Area, India

• Attended training in Ireland for knowledge transition• Led the validation efforts for multiple roll-outs of the GFSS system (Canada, Belgium, Germany, etc.,) • Instrumental in creation and review of Governance documents for various GFSS projects and non-GFSS projects in Pfizer (Validation Plan, Validation Report, GxP Assessment, and Traceability Matrix).• Assisted the development team in setting up the environment for QA system by cloning the PRD system to perform the validation… Show more • Attended training in Ireland for knowledge transition• Led the validation efforts for multiple roll-outs of the GFSS system (Canada, Belgium, Germany, etc.,) • Instrumental in creation and review of Governance documents for various GFSS projects and non-GFSS projects in Pfizer (Validation Plan, Validation Report, GxP Assessment, and Traceability Matrix).• Assisted the development team in setting up the environment for QA system by cloning the PRD system to perform the validation testing for each release and ensure version control using PVCS.• As an active member of the Audit team involved in the ISO audits of the Development team, cut-over team, Migration team to review the deliverables and the system and generate Audit Report. • Successfully passed out the Audit without non-conformance and few recommendations. Validation team got the appreciation for best practice followed by implementing CAPA process for Deviation Management.• Led the installation qualification activities to verify the Server license, patch upgrade, EDI interface connectivity and configuration verification. • Eliminated the Installation Qualification of Patch upgrade, configuration verification by implementing procedures.• Efficiently conducted and documented GxP Assessments for various minor projects.• Led the project for validating Remote Testing Tool which is 21 CFR Part 11 compliant developed by Pfizer for validation testing.• Involved in client interaction (face to face, teleconference, net meetings) for various project related discussions.• Created and reviewed Test scripts using the customized remote testing tool.• Created Standard Operating Procedure for Corrective and Preventive Action (CAPA), administered CAPA in TrackWise to ensure closure of open CAPA items in a timely manner by interacting with the functional team. Show less

Testing Web based applications.

Mca, Masters In Computer Science

Bachelors, Computer Science