SUMMARY

• Computer System Validation Analyst and have over 9 years of experience in Pharma industries
• Extensive expereince in developing CSV deliverables OQ Plan, OQ Summary Report and, RTM and maintained Requirements Traceability Matrix.
• Expereince in review, validation and creating process flows for integrated systems (Instruments & Auto - Lot Creation), eQRMS (CAPA), ERP (MES) and IT (R&D) integration like clinical reports.
• Performed extensive requirement analysis including data analysis and gap analysis.
• Used HP ALM for the OQ, IQ and PQ, Also for tracking and reporting Validation test defects.
• Hands on experience creating the Validation Protocols (IQ, OQ, PQ), Test Plans, and Test Scripts.
• Have strong experience in Functional, System, Integration, Instrument, Data Integrity and Regression testing in Agile and Waterfall Environment.
• Proficient with working in FDA regulated environment including 21CFR part11. Good working Knowledge of the GMP, GCP, GLP and GDP standards
• Strong knowledge on Master data for LIMS, configuration and implementation.

TECHNICAL SKILLS

FDA Regulations /Validation Protocols: 21CFR Part 11, 210/ 211, cGxP (cGMP, cGCP, cGLP), URS, FRS, RTM, IQ, OQ, PQ, SOPs, VSRs, GAMP 5, PUMA

LIMS: Labware LIMS, Stability, Environmental Monitoring

SDLC: Waterfall, V-Model, Agile

Database/Tools: MS SQL Server, Oracle, MS Access, SQL, TOAD

Defect Tracking: HP ALM, JIRA, Share point, Global Remedy

PROFESSIONAL EXPERIENCE

Confidential, Cambridge, MA

IT Quality

Responsibilities:

• Currently Working on Rave X enhancement, Change request, Rave EDC studies and CODE reports.
• Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
• Reviewing vendor documents, IQ,OQ, PQ, UAT and regression scripts for IT Quality on cross-functional teams with IT R & D in support of SDLC activities.
• Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations.
• Guidance, training and support to IT personnel in their validation efforts, to ensure compliance.
• Quality assurance oversight for system related issues (Test incidents, issues, etc.)
• Support/Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

Environment: MS office, imedidata Rave X, Studies, GxP 21CFR Part11, HP ALM, sharepoint, service now.

Confidential, Summit, NJ

Computer System Validation Analyst

Responsibilities:

• Implementation of Labware LIMS System - EM, CORE & Stability for Confidential CAR-T-cell therapy.
• Working with Business to gather requirement and complete functional requirement.
• Worked on UAT script, FR and prioritizing UR(User Requirement)
• Worked on the Computer system validation (CSV) of Labware LIMS system, EM, CORE & Stability module and performed testing on the multiple instruments integration and Master data management.
• Involved in reviewing User and Functional Requirements.
• Interacted with developers and end users in an Agile environment.
• Developed SOPs and Guideline documents for the Validation Team.
• Developed the Test Scripts as per PUMA methodology and followed Risk based approach.
• Test Scripts were reviewed and approved using eSignature in ALM
• Involved in the review and approve of test scripts, Test Set, Test Runs in ALM.
• Executed test scripts across multiple Environments (Development, Test &Validation) using ALM.
• Attended training sessions on GDPs (Good Documentation Practices) that must be followed as a part rigorous System, Integration, Data Integrity and Regression Testing.
• Involved in Validation of Lab Instruments TOC, Particle Counter, RS232 balance & scale
• Developed CSV deliverables OQ Plan, OQ Summary Report and, RTM and maintained Requirements Traceability Matrix.
• Tested integrated systems (Instruments & Auto-Lot Creation), eQRMS (CAPA), ERP (MES) and IT (R&D) integration like clinical reports.
• Evaluate change request and conduct impact assessment.
• Responsible for Electronic Data Integrity (DI) through Validation.
• Assisted in developing the Validation Plan and Validation Summary Reports.
• Gathered Business requirements for Integration points and mapped them with Functional requirements.
• Used Agile SDLC methodology - User Stories, Sprints, and Scrum meetings.
• Acted as a key facilitator bridging between the client, stakeholders and the solution teams in order to elicit, analyze, communicate and validate requirements for changes to information systems as well as business processes and policies.

Environment: MS Word, Labware LIMS 7, Pharma Template, GxP 21CFR Part11, HP ALM

Confidential, Parsippany, NJ

Validation Analyst

Responsibilities:

• Responsible for Computer system validation (CSV) Testing of Labware LIMS, Lot Management, Sample Management, Sample Collection, Result Entry, Release & Reports.
• Reviewed User and Functional requirements for the Labware LIMS and documented the required changes as per Computer System Validation Master Plan.
• Prepared and reviewed Computer System Validation deliverables, periodic review report, Test cases Validation Reports
• Created the Validation Test Plan and Test Criteria.
• Experience in testing integrated systems, Trackwise (CAPA), ERP (MES).
• Developed the Functional Risk Assessment for the system in collaboration with Business and IT.
• Responsible for Electronic Data Integrity (DI) through Validation.
• Developed the process flow in consultation with the business and process teams.
• Developed and Reviewed the OQ & PQ scripts
• Co-coordinated with Systems owner and Business analyst to setup Pre-Validation and Validation environment to execute the scripts.
• Executed OQ Scripts in Test & Validation Environment and followed the Test Script approval process flow in ALM
• Logged and Managed the Defect in ALM.
• Used HP ALM for the OQ testing and also for tracking and reporting Validation test defects.

Environment: MS Word, Labware LIMS 7, Pharma Template, GxP 21CFR Part11, HP ALM

Confidential, Richmond, VA

System Analyst

Responsibilities:

• Acted as a key facilitator bridging between the client, stakeholders and the solution teams in order to elicit, analyze, communicate and validate requirements for changes to information systems as well as business processes and policies.
• Understood business problems and opportunities in the context of the requirements and recommended solutions that enable the business to achieve its goals Led and increased performance with accuracy for a team to processing mail and branch deposits.
• Led requirements elicitation, definition, and documentation with business and partner teams.
• Gathered requirement and performed contract data search and analysis, data collection and grouping, data entry, data checking, data validation, and data clean-up.
• Assisted with Defect Management using JIRA.
• Designed and instituted a daily balancing tracker used by deposit operations staff to measure and enhance productivity
• Facilitated functional requirements walkthroughs with developers and testing team.
• Documented BRDs, Workflow diagrams, Wireframes, and Acceptance Test Cases for Product
• Reporting requirement for Cognos like sales by region/country/states, forecast sales, projection.
• Contributed to Project deliverables and metric development under the direction of the Project
• Manager by providing progress against outstanding milestones, status, resource requirements, issues, risks and dependencies on large projects
• Contributed to development of test plans, user guides, reference manuals, training materials and code release artifacts as appropriate.
• Assisted in roll-out strategy as an active participant in user training and post production support needs.
• Self-directed, with demonstrated ability to multi-task, prioritize and execute on executive strategies.
• Ability to balance a heavy workload with conflicting demands and tight timescales.

Environment: CRM, OracleDB, SQL plus, Jira, Cognos, ITP.

Confidential, Greenville, SC

Business Analyst/Quality Analyst

Responsibilities:

• Gathered Business Requirements, created Functional Requirements Document (FRD) and analyzed data/workflows; defined the scope, financial projections and cost/benefit analysis; progressed from Problem Statement to well-documented designs.
• Used RUP-iterative process to Conduct Data Analysis on the Group Disability Data to find missing data fields in the application and customize them.
• Acted as resource and technical support specialist on insurance matters
• Gathered Business requirements for Integration points and mapped them with Functional requirements.
• Analyzed Business Requirements from Black Box testing perspective; reviewed Test Strategy, Traceability Matrices and Test Plans to ensure that test cases reflect user needs for the functional, performance, usability and security requirements.
• Administered User Acceptance Testing (UAT) to ensure that insurance agents can use application with ease.
• Trained and effectively used the GAIS system.
• Outlined requirements for client communication templates for Annuities, Whole-life, and Universal-life.
• Performed requirement analysis, went through all the use cases and issue logs and helped team organizational team member in designing and drafting different life insurance, auto and commercial quotes.
• Performed extensive requirement analysis including data analysis and gap analysis.
• Wrote SQL queries to validated data in SQL Server.
• Used Quality Center for requirement management, defect tracking, and mapping requirements to test cases.
• Participated in Defect Management calls and provided feedback on UAT defects.
• Collaborated with the QA team to ensure adequate testing of software both before and after completion, maintained quality procedures, and ensured that appropriate documentation is in place.

Environment: Quality Center (ALM), MS Visio, IBM ClearQuest, MS Office, Oracle, SQL Server