- 7+ years of experience in gathering business requirements, defining business process flow, business/data/system analysis, business process modeling, etc.
- Experienced in SDLC, Waterfall, Scrum, Agile and Sprints and worked on Planning, Grooming, Retrospectives, and other Scrum activities.
- Proficient in using UML for Business Process Modeling, Use Cases, Activity Diagrams, Sequence Diagrams, Data Flow Diagrams, Collaboration Diagrams, Class Diagrams, Workflows, Wireframe prototypes and document them using Microsoft Visio, Balsamiq, etc.
- Experienced in conducting Joint Application Development (JAD) sessions, project meetings, reviews, walkthroughs, and customer interviews.
- Variety of CTMS, Data Management, Technical and Clinical Trial experience gives me the ability to fully understand business process of pharmaceutical Companies.
- Multi - skilled Life Sciences professional with progressive experience in the Laboratory, Operations Management, Leadership, Data Management and Customer Relations.
- Creating user requirements document by interacting with the end users and developers.
- Knowledge and working experience in GLP, GMP and GCP suites.
- Participation in 21 CFR Part 11 and GxP compliance assessments and Implementation of 21 CFR Part 11 regulations.
- Skilled in implementing Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) in the clinical research environment.
- Extensive experience in preparing and executing qualification protocols (IQ, OQ, PQ).
- Proficient in dealing with Standard Operating Procedures (SOPs), Test plan, Laboratory information management system (LIMS).
- Experienced working in a team-oriented, collaborative environment provided by Business analysis GLP GXP Clinical, GMP Use Cases, wire frames
- Implemented and maintained a GxP compliant QMS.
- Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current pharmaceutical industry standards.
- Expertise in writing Business Requirements Document (BRD), Functional Specification Document (FSD), Non-Functional Specification Document, System Design Specification, Use Cases, screen mockups, and training manuals.
- Expertise in change request management and underwriting management documents.
- Hands on experience in creating SQL Queries, T-SQL Stored Procedures, Triggers, Views, Indexes in SQL Server with a strong understanding of data & analytics.
- Significant experience in conducting User Acceptance Testing (UAT) verifying performance, reliability, and fault tolerance issues.
Project Management Tools: Microsoft Office tools (Project, Visio) Access, Excel, Outlook, and PPT
SDLC/Design Methodologies: Unified Modeling Language (UML), RUP, Agile, and Waterfall
Requirements/Document Tools: Rational Requisite-Pro, Rational Clear - Quest
Modeling and Design Tools: Rational Rose, Microsoft Visio, MS Office
Databases: SQL Server, MYSQL, PL/SQL, Oracle, Access.
Hardware skills: Basic Hardware Knowledge of Computer System.
Operating System: Windows, Linux
Confidential, Exton, PA
Sr. Business Analyst
- Facilitated Agile Scrum ceremonies with Scrum Master for specific technical tracks including sprint iteration planning, story grooming, daily stand ups, sprint retrospectives and release planning - Scrum Project across all disciplines of the organization.
- Participated in Inception phase, worked with SMEs and product owners to understand the current process, suggested process changes and re-engineered where needed.
- Assured delivery of number of documents in a timely and efficient manner. (BRD, Wireframes, Style Guide, Copy document, Technical flow diagram etc.)
- Analysis of the Functional Requirements for Bio-Analytical.
- Responsible for Writing of OQ scripts for modules-Assay Design, Plan Analytical Runs, Study Design, Study
- Configuration, Bi-Directional Instrument Interfaces with LIMS, Sample Handling, and Sample Tracking in client’s LIMS system.
- Created custom enhanced reports in ALM and using complex SQL queries and Business Views
- Executed IQ, OQ and PQ testing protocols for Labware LIMS.
- Worked on ELN, SOP’s, LIMS, CTMS system integrations for the client.
- Responsible for initial and thereafter annual training for all employees for cGMP (21 CFR Parts 210, 211 and 820), cGLP (21 CFR Part 58).
- Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
- Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts.
- Involved in conducting Performance Qualification (PQ) to test the performance of the system according to business requirements.
- Analyzed Requirements and created Use Cases, Use Case Diagrams, Activity Diagrams using Visio.
- Involved in validating all Network Devices that are interacting with Lab Instruments.
- Conducted routing Internal inspections of regulated systems (GMP, GCP, GLP) to assure validation procedures have been followed in compliance with company, divisional and departmental policies and predicated rules.
- Translating business needs into system requirements following Agile methodology.
- Worked with SAP functional team to validate the transactions and modules to be complaint with 21 CFR Part 11 and GMP regulations.
- Wrote test cases for functionality, system and integration testing and tested the application manually and using HP ALM.
- Responsible for day-to-day support of enterprise backups and disaster recovery systems in a 7x24 support schedule.
- Experienced in testing Lab vantage LIMS system, which is an Laboratory Information Management System involving functional and user-acceptance testing.
- Involved in development of Master Test Plans and Test Scripts in OQ and PQ/UAT.
- Involved in Pre-execution review of OQ and PQ/UAT scripts and incorporated negative test steps to challenge the system. Also involved in Post review to verify the compliancy and documentation of scripts according to GDP regulations.
- Responsible for executing the SharePoint on-prem to O365 content migration process.
- Conduct meeting with different content owners to understand their existing data’s and process flow before migration and workflow development.
- Responsible for creating classic page and modern pages based on the business needs in the new interface.
- Create and maintain site level metadata’s and tag for all the necessary contents based on user need for providing better search result.
- Used JIRA for logging the defects and SWORD for keeping track of all test plans and test cases.
- Working with Pre-prod support team to assess the validity of the defect using Jira Tool.
Environment: SQL Server, Microsoft Visio, Oracle, DML, MS Office Suite, O365, Quality Center/ALM, JIRA
Confidential, Memphis, TN
- Gathered requirements and conducted interviews with business users and Project Manager to understand the needs.
- Successfully used Agile/Scrum Method for gathering requirements and facilitated user stories workshop. Documented User Stories and facilitated Story Point discussions to analyze the level of effort on project specifications
- Work with the business users to understand & document the functionality requirements
- Utilize TFS (Team Foundation Server) as agile tool to manage product backlog items and sprint tasking.
- Wrote business requirements specification (BRS) and functional requirements specification (FRS) documents as per the business requirements and process flow.
- Involved in validation of Labware LIMS system rollout project.
- Developed Validation Strategy and documented in Validation Plan.
- Prepared Operational Qualification and User Acceptance Test Plans.
- Wrote and executed Operation Qualifications and Process and Product Validations.
- Involved in development, review and execution of validation documents, generating and executing SOPs and protocols, conducting testing, and preparing final summaries.
- Performed extensive research into business strategies for establishing an independent PBM and working directly with more established PBMs in the process.
- Developed Requirement Traceability Matrix and Risk Assessment documents.
- Prepared Deviation reports as part of OQ testing and kept track of all deviations occurred.
- Developed Test Summary Reports and Validation Summary Report.
- Analyzed business requirements and developed test plans, test cases to cover overall quality assurance system testing.
- Took an active part in sizing of the CTMS project.
- Created Project charter and RAM for the CTMS-Noetix integration Project.
- Directly report and interact with IT Management, IT staff and end-users to plan and implement technology solutions for IT Disaster Recovery Operations.
- Oversight and execution of a risk based GXP Supplier and Partner management program including Pharma vigilance and IT software / software as a service (SaaS) provider
- Utilized Veeva Vault software for routing process of GMP documentation.
- Performed under Regulatory Compliance (GxP, FDA/GLP).
- Tracked defects in HP ALM and worked with QA team to resolve defects.
- Involved in Change Control Processes to keep track of all the changes made to the validated environment.
- Developed Master Test Plan and system test scripts for an Oracle Clinical upgrade project as part of computer system validation.
- Involved in validation of Oracle Clinical business processes in accordance with EMEA and FDA regulations.
- Approve SDLC defects closure with relevant root causes and suitable CAPA in JIRA & HP- ALM.
- Make sure the SDLC Agile methodologies and practices are sustained across the SDLC Life cycle.
- Work with ETL team to understand data load/data mapping issues to make sure data warehouse tables are developed as per the business requirements.
- Maintained formulary tables in PBM system to add, update or remove drugs and change pricing.
- Developed Operational Qualification Test Plan and documented OQ test strategy.
- Involved in preparation of Operational Qualification (OQ) test scripts as part of OQ test cycle.
- Worked closely with QA team to identify the test scenarios and test cases.
- Included negative test steps in the test scripts to challenge the system against system requirements.
- Developed test summary reports to summarize the test results according to company Standard Operating Procedures.
- Developed test scripts to ensure that the system is compliant with 21 CFR Part 11 and GMP regulations.
- Documented deviation reports and maintained deviation report log for tracking during OQ testing.
- Developed Performance Qualification (PQ) Test Plan and documented PQ test strategy and test scope.
- Developed and executed test cases, test scenarios and followed-up defects using TFS.
Environment: Microsoft SharePoint, .Net, MS Visio, PL/SQL, MS Office, Microsoft Project, Google Analytics, UML Iterative Process Methodology, Team Foundation Server