Professional Summary:

• Over7 years of professional experience in IT industry with specialization in the areas of Computer Systems Validation and Testing profound knowledge of FDA 21 CFR Part 11, 21 CFR Part 820andotherGxP Regulations.
• Strong experience in developing executing protocols. Experience includes Validation Master Plans, IQ, OQ, PQ Protocols, Trace Matrices, Validation Summary Reports and other SOPs.
• Outstanding experience in validating automated systems in pharmaceutical companies by implementing Good Automated Manufacturing Practices GAMP .
• Excellent experience in the validation of highly regulated enterprise level business systems SAP, Siebel CRM, Labware Laboratory Information Management System LIMS , Clinical Trial Management System CTMS , Trackwise, Inventory Management System and Remedy.
• Experience in validation of Quality systems like Application Server, Disaster Recovery system, Back Up Server, Supplier Audit Database and Controlled Spread sheets.
• Hands on experience in Technical Writing, implementing QA Audits/Methodologies, Test Plans, Test cases and Test documentation.
• Environmental monitoring
• Strong experience in implementing Good Documentation Practices GDP in writing and reviewing validation deliverables.
• Good understanding implementation knowledge of cGxPs GMP, GCP, GLP .
• Good working knowledge of Quality Management Systems QMS like Remedy and Trackwise.
• Experienced in all the stages of the SDLC Software Development Life Cycle VLC Validation Life Cycle .
• Good understanding implementation knowledge of Good Testing Practices GTP .
• Experience in performing GUI, White Box/Black box Unit Functionality ,System Integration, Regression, Performance UAT User Acceptance Testing testing.
• Good experience in using automation tools like QTP, WinRunner, and Load Runner Rational Suite and in designing and development of queries using SQL, PL/SQL.
• Good knowledge of Industry standards like ISO 9000.
• Strong analytical, presentation and communication skills with quick assessment problem solving approach.
• Diligent worker, self-starter and consistent performer, adaptable to work as a team member as well as independently.

Technical Skills:

Professional Experience:

Confidential

Sr. Validation Consultant

Responsibilities:

Implementation of Siebel CRM Upgrade, Managed open change controls in Trackwise

• Involved in Validation activities for multiples releases within Siebel CRM.
• Reviewed and edited the URS/FRS/DS documents of Siebel CRM.
• Developed Validation plans VP to define validation strategies for Siebel CRM including Infrastructure Qualification and deployment.
• Involved in validating the TrackWise CAPA Corrective Action Preventive Action Business Workflow
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Executed test cases to verify TrackWise functions, Workflow, Queries, Scope, End-End flow Approvals, permissions and Reports
• Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports VSR .
• Developed and executed IQ/OQ/PQ test plans and test scripts.
• Reviewed the edited URS/FRS/DS documents as per the change request.
• Involved in periodic auditing of the change management systems to ensure that the change management systems are in compliance with SOP.
• Executed Black Box, Negative, Regression, and Integration Security Tests as per the test plans and test scenarios
• Involved in Validation activities for releases within Siebel CRM.
• Reviewed and edited the URS/FRS/DS documents of Siebel CRM.
• Involved in Data Migration End-to-End testing including executing the test procedure and writing the Test Analysis Report for Data Migration End-to-End System Test.
• Involved in the Change Advisory Board CAB meetings to discuss the GxP/PDMA impact of new change requests and the compliance risk level associated with the change.
• Involved in the discussions with business and IT managers on the status of open change controls.
• Reviewed and approved the test execution scripts in Quality Center.
• Managed the testing process in Quality Center
• Ensured that application is in compliance with 21 CFR Part 11 and cGxP regulations.
• Ensured that all the change controls are in compliance with GxP/PDMA regulations before they are closed out.

Confidential

Job Description

Responsibilities:

• Created end to end business and functional requirement specifications documents.
• Was involved in the Validation of EnterpriseLabware LIMS in accordance with company's policies.
• Developed Use Cases and Business Process Diagrams using MS Visio.
• Interviewed the Business Users for gathering Business Requirements.
• Involved in validating the application according to 21 CFR Part 11 requirements.
• Followed the SDLC process and involved in all stages of project to develop validation deliverables.
• Involved in writing the computer system validation Risk Assessment documents, Validation Plan, Test Summary Reports and Validation Summary Reports.
• Created OQ/PQ Scenarios in MS Visio. These scenarios were elaborated into detailed test scripts.
• Involved in the creation of IQ/OQ/PQ Test scripts.
• Involved in executing the test scripts of SD, MM, PP, WM, IM modules of the SAP implementation.
• Executed the test scripts along with Business users and created deviation reports.
• Worked with the Business users in prioritizing the defects and planning for enhancements.
• Developed/Maintained the Requirements Traceability Matrix RTM .

Confidential

Validation Consultant

Responsibilities:

• Developed the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document.
• Developed the Validation Plan VP for SAP implementation by following the corporate guidelines.
• Collected User Requirements URS for Trackwiseby interacting with the users and developed Design Specification DS for conformance with 21 CFR Part 11 based on the requirements.
• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing.
• Followed good test practices to document the test evidence Screen Prints , Deviations, Resolutions, and Corrective Actions.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.

Confidential

Responsibilities:

• Analyzed User Requirement Specification URS and developed Functional Requirement Specification FRS by interacting with the users for Siebel SFA system.
• Developed cGMP related quality system requirements for Siebel Sales Marketing applications.
• Involved in development activities including preparation of System Design Specification SDS .
• Prepared documentation for all aspects of the Computer Systems Validation CSV lifecycle, in accordance with FDA regulations including 21 CFR Part 11, GMP and GLP.
• Involved in validation of Siebel system application including preparation of protocols.
• Involved in writing Installation and Operational Qualification Test Scripts and Test Plans.
• Performed Build Verification, Positive, Negative and Boundary, Functional, Integration, System and Regression Testing.
• Performed Performance Qualification Such as Load/Stress, Volume and Response Time and User Acceptance Tests UAT and also documented them.
• Performed Global adverse effect case data management and regulatory reporting to the industry using Argus safety
• Wrote the Standard Operating Procedures SOP's for LMS by following the departmental and company SOP's.
• Developed and reviewed Traceability Matrix TM .
• Developed and reviewed GxP computerized system documents including those related to system performance, compliance evaluation and validation.
• Participated in various meetings and discussed Enhancement and Modification Request issues.