SUMMARY:

• Validation Lead for a large SAP Program (S/4 HANA 1610 green field implementation) governing the process and procedures 100 plus applications, 450 plus interfaces and 21 Service providers
• Experience in leading large complex projects with global teams. Strong experience with Agile methodology and Vendor relationship management
• Implemented SAP ERP system at Three (3) Life Science Companies(Sanofi, JNJ and CSL Behring)
• Developed the Validation Strategy, Validation plan and risk assessment for the project
• Excellent experience in dealing with the compliance issues/concerns and providing guidance and recommendations /resolutions by evaluating the risk
• Extensive experience on FDA's regulations and 21 CFR Part 11 compliance assessments
• Expertised in Project and Test management - planning, scheduling and monitoring, Onsite-Offshore communication, Customer Interaction
• Active participation in Risk Mitigation process for the risks identified for systems as a part of the assessment
• Monitored adherence to SOPs and standards and plan, perform and coordinate periodic quality reviews of processes and key deliverables
• Created, tracked, reported and followed-up timely completion all relevant remedial strategies resulting from Corrective Action Plans (CAPAs) identified during Audits, SOP deviations
• Participated in Audits and performed Service provider Assessments for Business Vendors for Security and Privacy
• Managed a peak team size of 50 members at both onsite and offshore with 5 leads reporting directly

SKILL:

• 21 CFR Part 11 assessment
• SAP S/4 HANA 1610
• Validation Plan
• Initial Risk assessment
• GxP Assessment
• SAP Modules: FICO, MM, QM, OTC, SOP
• HP ALM and JIRA
• Test Management
• Traceability matrix
• Effective Communication Leadership

WORK HISTORY:

SAP S/4 HANA Validation Lead

Confidential, King Of Prussia, PA

Responsibilities:

• Developed the Validation strategy, Validation Plan for CSL PACE project that validated the installation of SAP Hana 1610 for the S4 HANA, MDG (Master Data Management) and CSL Bridge releases and Validation of ERP modules included FICO, SD, MM, PP, QM, CRM, BW and Change Control.
• Performed Initial risk assessment and Functional risk assessment on the high business critical functionalities
• Approved all the GxP Test Cases and Defects
• Validated Solution Manager 7.2 to approve the SAP transports.
• Managed the SAP Defect resolutions, reports and approvals within the HP Application Lifecycle Management module to ensure compliance with CSL and Regulatory standards.
• Maintained documentation and reports with CSL's document management system GDRS (EMC Documentum WebTop 6.7)
• Managed Change Control

SAP ECC Validation Lead

Confidential, Bridgewater, NJ

Responsibilities:

• As Validation Lead responsible to manage the end to end validation activities and make sure the team adheres to the Quality and Compliance process
• Authored Initial risk assessment and GxP assessment document for the system
• Authorized to approve all User Requirements and Functional Specification documents created by the team
• Managed the overall quality of the deliverables and validated that the team is adhered to Good Documentation practice.
• Responsible for project plan, managed the changes in the Project Planning, Effort Estimates, and tracked activities against the documented project plan, and coordinated with other IT projects, as needed with other Business Groups.
• Monitored control over the project's status and managed quality and timelines of the deliverable.
• Worked closely with senior stakeholders, involved in negotiation for dates, and required approvals She Managed and Coordinated Risk Assessments Program for 100 applications and 21 Service providers.
• Manged compliance & risk management guidance for GxP Systems and Processes, including the evaluation, recommendation and implementation of technical controls.

Validation Specialist

Confidential, Bridgewater, NJ

Responsibilities:

• As a Validation Responsible authored the Validation strategy and Validation Plan
• Collaborated with business users to the Initial Risk assessment, Critical Data Assessment and Functional Risk Assessment
• Approved the User, Functional specification, Requirement Trace ability Matrix, System and UAT Test protocol, System and UAT reports

Test Manager

Confidential, Bridgewater, NJ

Responsibilities:

• Responsible as UAT Test Manager and played liaison between Confidential Business Users/QA Testers/Application Development Team
• Directed off-site teams completing User acceptance testing and to support successful product development stages and releases.
• Planned and devised cohesive UAT Test Strategy for GA UAT projects
• Responsible for review of Use cases and highlight the gaps
• Conducted meeting with AD team /Business users/QA team for resolving ambiguities in use cases
• Responsible for fixing the defect prioritization during defect migration through calls with all stake holders
• Lead a team of 7 to ensure the delivery of GA UAT
• Notified Early Risk to Confidential Project Manager during weekly status report
• Wrote and optimized test cases to maximize success of manual software testing with consistent, thorough approaches.
• Gathered data on integration issues and vulnerabilities and reported all findings to all stakeholders with improvement recommendations.

Sr.Software Engineer

Confidential

Responsibilities:

• Lead a team of 15 for Project delivery
• Worked as QA Test Lead and QA coordinator between Dell product users with 5 Development team and 4 testing team
• Conducted meeting with Business users/QA/Dev Leads for completion of end to end testing
• Responsible for building the end to end scenarios and review with business
• Involved in estimation of Project and resource loading in various project modules
• Conducted defect triage with all stake holders during Integration Testing and User Acceptance Testing
• Responsible for fixing the defect prioritization during UAT and SIT
• Managed quality assurance program including on site evaluations, internal audits and customer surveys.