- More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis; Data Analysis and Management; Software Application Testing; Document Management; Change Control and Release Management
- FDA Compliance Verification and Validation; Quality Assurance Processes and Methodologies; Developing Testing Strategies and Test Plans; Test Scenarios and executing Test Cases for carrying out End to End Testing; Regression Testing; Systems and Integration Testing; User Acceptance Testing and Usability Testing for Business Applications and Web Services.
- Proficient in Agile Methodology and various Testing phases for Clinical Trials for different Pharmaceutical clients including GUI Testing, Functionality Testing, Security Testing, System Testing, Regression Testing, Integration Testing, Back End Testing (Oracle tables manipulation - using SQL), FDA 21-CFR Part 11 rules and regulations and under GMP environment.
- Besides I have over 14 years of IT experience in the analysis; design; development and implementation of IBM Mainframe and Oracle RDBMS based Enterprise Business Applications and ERP Packaged Solution in the Corporate Systems Management Division for India’s leading Industrial group
Tools: and Testing Software: PowerPoint, Word, Excel, Master Control, Rational Robot, FDA rule 21-CFR Part 11
Tracking Tool: Test Director, Rational Clear Quest, ServiceNow, Quality Center
Programming Languages: Cobol, SQL, Oracle
Databases: Oracle 8i, SQL Server 6.5 / 7.0, MS Access2000
Operating Systems: UNIX, Windows NT/2000, Solaris 8.
Protocols: TCP, UDP, SMTP
- Main responsibility is to see online EVA and XP storage migration documents are as per Compliance and QC.
- Participate in the meetings to drive series of process improvements for online EVA & XP migration project.
- Follow up with engineers for documents which are of high quality per compliance.
- Participated in the reviewing and finalizing templates for EVA and XP Migration.
- Create change control tickets for online EVA and XP projects in ServiceNow tool for server migration project.
- Follow up with engineers for completing documents for change control.
- Responsible for the closing Change Request in ServiceNow tool.
- Main responsibility is to implement Change Control Software System to automate paper-based Change Control/Change Management Processes in Regulated Environments & assure Enhancement in Productivity.
- Analyze the current processes of Abbott Lab Point of care and carried out gap analysis to finalize future state business processes.
- Gather Requirements to implement Change Control Process & Design Control Process after meeting with end users based in Princeton and Ottawa.
- Developed Business Process work flows using MS-Visio for Master Control Team.
- Conducted few sessions with end users to finalize business processes and work flows.
- Developed URS for web based system to capture business process changes for Master Control System.
- Organized meetings with Master Control team and helping end users to understand how master control works & helped Abbott business users to automate business process and achieve paperless environment for the QA department.
- Help the validation team in creating a knowledge repository for validated documents.
Senior QA Analyst
- The Engagement Management System (EMS) developed by Confidential is a leading edge system that gives practitioners the capability to create, conduct, and document an audit to meet the unique needs of every client engagement.
- Performed testing the functionality of Engagement Management System (EMS)
- Worked closely with all members of the software development team to test functional and business requirements and to ensure high quality deliverables.
- Analyzed business requirements and carried out URS review and provided feedback to the team.
- Performed Functional and Regression Testing for major builds 3.1 and 3.2.
- Tested both releases under Agile methodology.
- Involved in gathering and documenting User Requirements team approval. Used Quality Center tool to write and execute Test Cases.
- Created Test Cases and Test Scenarios to cover business functionality, like procedures, risks and common tools like Tick Mark, Cross Reference, and Review Notes and mapped them into QC requirements module with the project requirements.
- Developed and executed manual script based Test Scripts.
- Created Engagement files and sync them with server and Peer to Peer to test the functionality for data movement.
- Recorded defects and coordinated resolution with development team and functional leads.
- Utilized TFS and Rational Clear Quest for Defect Tracking and maintained Defect Repository and followed Defect Life Cycle until it was closed
Environment: Quality Center 10.0, SQL Server 2008, Rational Clear Quest, Team foundation server (TFS) .
Senior Systems Analyst
- Responsible for establishing Clinical Trial frame work; conducting Requirement analysis and recommending best practices; Participating in Impact Analysis and FRS review; Writing and conducting review of Test cases. Set up studies in Test environment from the latest base line; set up data for the study; execution of Test cases; Developing internal User Acceptance Test and Client User Acceptance Test Plan and data set up accordingly. Responsible for tracking till execution is done by Project Specialist or by client.
- Additional responsibilities are to work with management to develop effective ways to increase system reliability and quality
- Writing and executing test cases for all modules of IVRS/IXRS Study application and products supporting P harmaceutical Clinical Services Organization.
- Maintain Clinical Trials Study Documents in Master Control Tool.
- Developed and executed manual test scripts.
- Perform functional testing, integration testing and user acceptance testing.
- Performed black and white box testing and regression testing
- Responsible for documenting test results in test plan after executing test scripts.
- Responsible for keeping all error request generation in IBM Clear Quest till the time they get resolved.
- Involved to convert complex functionality into small Visio diagrams to have better understanding for the team.
- Ensure Data Setup, Writing and execution of all IXRS modules and Drug Management.
- Ensure correct testing of Internal Inventory and other subsequent build reports. .
- Ensure the validation group to meet all requirements of documentation and responses to Audit findings.
- Ensure full understanding of and compliance to, the ALMAC SDLC Processes.
- Ensure that all protocols for the studies have been validated under FDA 21 CFR Part 11, Gxp regulations and guidelines - predicate rules defined in SOPs (standard Operating Procedures) and WIs (working instructions).
- Mentor subordinates and new employees until deemed trained.
- Manage and prioritize work load and escalate conflicting schedules to Group leaders.
- Participate in client audits and assist Quality Assurance group with responses to audit findings.
- E nsure communication of Project test status to Project team members and for the timely delivery of all test deliverables (Internal and External).
- To ensure improve quality for core mods applications for different clients.
- Other responsibilities assigned by the Management like Coordinate Project test effort when multiple test analysts are on the team.
- Ensure Unit Testing using SQL before release comes to test. Good knowledge of SQL, and executed SQL statements
- Successfully engage in multiple initiatives simultaneously i.e. modifying/creating SOPs and WIs.
- Proactively communicate and collaborate with external and internal teams to analyze information needs and functional requirements and deliver URS/BRS, test cases, test plan, and Traceability Matrix.
- Ensure to test application with test scripts and Validation reports under Agile methodology.
- Responsible for activities like tracking, co-ordination, and deadlines of the projects.
Confidential, New Jersey
Data Management Analyst
- Responsible for developing Requirement Specification, Critical Release Plans, Test Plans across IMPACT, e-DAD and R-IPET Projects for different releases as per NAVIGO till production to release memo.
- Responsible for Unit Testing and System Testing of different releases of IMPACT.
- Responsible for Integration Testing between SAP and IMPACT Vendor Management System.
- Act as System Test Lead for IMPACT 3.3.5 release in Oracle Environment for Financial, Planning and Monitoring Modules and IMPACT.
- Wrote all System Test Scripts and data setup.
- Maintain Test tracker for tracking all the activities of System Testing.
- Responsible for writing Critical Release Plan, Traceability and Test Summary Report to in corporate all testing strategies.
- Wrote & run SQL queries for Verification against online values database.
Environment: Oracle 9i application server, 10g server and UNIX.