SUMMARY

• Almost 7 years of experience in the field of Computer System Validation, Equipment Qualification with concentration in Pharmaceutical and Medical device industries.
• Proficient knowledge on methodologies such as Waterfall Model, V - Model and Agile Methodologies.
• Good understanding of 21 CFR Part 11 cGxP requirements including Electronic Records (ER), Electronic Signatures (ES), system validation strategies and documentations.
• Familiar with quality system and standards, cGxPs (cGLPs, cGCPs, and cGMPs) and regulation of drugs and medical devices.
• Good knowledge in medical/pharmaceutical device regulations such as FDA 21 CFR part 11, 210, 211, and 820.
• Experience in preparing and documenting reports such as change control, validation summary report (VSR), validation master plan (VMP) and Requirement Traceability Matrix (RTM).
• Command on authoring, reviewing and approving various documents associated with computer systems validation following the required GxPs.
• Knowledge in GAMP 5 guidelines and Software Development Life Cycle (SDLC), development of User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).
• Experience in reviewing and approving the documents in validation including SOPs, IQ, OQ and PQ documents.
• Experienced in initiating, analyzing and resolving defects in defects module.
• Pulled tractability matrix from Analysis View to verify if all the requirements were tested during protocol execution.
• Worked on Data Migration projects.
• Knowledge in various testing such as Integration Testing, Regression Testing, System Testing and data driven testing and writing test documents including Test Plan, Test Cases, Test Design Specifications and Test Procedures.
• Good knowledge about various instruments such as HPLC, GC, GC-MS, LC-MS and their LIMS applications.
• Knowledge in creating ‘source to Target’ Data Mapping.
• Created and maintained Test Scripts using Test Management tool.
• Working knowledge on Scrum methodology.
• Experience of working with various systems such as Change Control Management System (CCMS), Electronic Data Management System (EDMS), Adverse Event Reporting System (AERS) and Laboratory Information Management System (LIMS).
• Good knowledge in Test Planning, Test Effort Estimation and Test Strategy Creation.
• Experience in CSV Risk Assessment Evaluation in compliance with FDA guidelines.
• Experienced in client facing consulting engagements.
• Knowledge in Change Control Methodology, Corrective Action and Preventive Action (CAPA).
• Good communication skills, writing skills, analytical skills, quick grasping ability, adaptability and excellent performance as an individual as well as a part of team.

TECHNICAL SKILLS

Validation: 21 CFR part 11 (210, 211, 820), cGxPs (cGMP, cGCP, cGLP), IQ, OQ, PQ, SOPs, Summary reports, Risk Assessments, CAPA

Application: LIMS, AERS, EDMS, CCMS

Testing Tools: HP QC / ALM, Jmeter, Win Runner, Load Runner, Toad.

Methodologies: Agile, Waterfall and V model.

Operating systems: Windows MS-Doc, 2000, 2003, XP, Vista,7, 8, 10.

PROFESSIONAL EXPERIENCE

Confidential, Princeton, NJ

Validation Test Engineer

Responsibilities:

• Worked on a Remediation project for SAP system andRetrospective validation of Electronic Records Management System (ERMS)
• Worked on an Upgrade project for Electronic Document Management System (EDMS)
• Performed a tracing exercise to find the gaps within the historic testing for the remediation of Mercury R6/SAPsystem (Inventory Management system).
• Reviewed the SOPs and WIs to find the issues and gaps existing within them and logged them for revisions.
• Worked on defect tracking, defect review, validation and root cause analysis.
• Guided the end users on the test execution process of the Business Process Test Scripts.
• Execution of test scripts and reporting using QC.
• Worked closely with end users and Quality Assurance team to identify the defects found during the testingprocess and worked on the defects to get them closed.
• Executed IQ, OQ, PQ protocols.
• Involved in requirements gathering sessions with Business team to determine and develop the FunctionalRequirements Specification (FRS).
• Developed and Maintained Requirements Traceability Matrix (RTM) to track the changing requirements andmap Functional Requirements Specification to User Requirements Specification.
• Authored Technical Design Specification and Functional Requirements Specification for the system.
• Performed Dry Runs and updated test scripts for Core System testing, Reports Testing and User AcceptanceTesting (UAT)
• Developed and executed Test Scripts for core system testing, Reports testing and User acceptance testing.
• Worked on Data Warehouse and ODS/Data Mart.
• Sorted the Functional Requirements based on the functionality and developed a matrix to track the requirementscovered in each test script.
• Created Test Scenarios, Test Cases and Test Conditions.
• Updated the workflows according to the changes in the system.
• Involved in sessions with vendor to gather configuration specifications of different modules.
• Analyzed Vendor documents and sorted out the Out of the Box Functionalities to minimize the effort of system testing.
• Updated the Technical Design Specification to reflect the changes made to the current system.
• Performed dry runs and updated Test scripts for Electronic Document Management System (EDMS).

Confidential, Westbury, NY

Validation Analyst

Responsibilities:

• Involved in Oracle Argus and TrackWise Validation, the work involved review and approval of validation deliverablesfrom compliance perspective.
• Developed the Validation Assessment Plan for the management to provide them a brief review ofobjectives (Validation Deliverables and Level of Testing) to be captured during validation of Argus SafetyImplementation.
• Worked on Defect tracking, Defect review, Validation analysis and Root cause analysis.
• Review and Approval of Business Process Definition (Requirements) and Technical Functional
• Specifications (Design and Configuration) documents for Plant Maintenance and Manufacturing Executionin Solution Manager.
• Review and Approval of Test Plan to include all the System Functional Tests from different modules PlantMaintenance, Manufacturing Execution, Quality Management, and Warehouse Management.
• Review and Approval of System Functional Tests for Plant Maintenance and Manufacturing Execution inHP Quality Center
• Pre-Review of Test Scripts in HPQC (Test Plan) to verify the Description / Action, Expected Results aretraced to the correct Functional Requirements
• Post-Approval of Test Scripts in HPQC (Test Lab) to verify the Actual Results match the Expected Resultsand verify the Objective Evidence
• Review and Approve Requirements Traceability Matrix (RTM) to Trace Functional Requirements toDesign to Testing Protocols
• Guide the Validation team to Address Deviations during the execution of System Functional Tests usingthe Defects Module in HPQC.
• Link the Deviations to System Functional Tests, Pre-Approve deviations in HPQC and close the deviationsonce the Resolution is completed.
• Review and Approve the Test Summary report to include the Summary of Testing and Deviationsencountered during testing.
• Review and Approval (Pre and Post Approval) of User Acceptance Tests from a Compliance Perspective.
• Authored the Validation Summary Report to capture the Developed Validation Protocols and verify that theAcceptance Criteria as established in the Validation Plan is met
• Reviewed Quality System Procedures (QSP’s) to define the Validation Life Cycle and supporting activitiesfor Computerized System Life Cycle Process
• Developed Templates for Authoring Validation Documents and Test Protocols.
• Participated in preparing and presenting weekly presentations for the updates and progress of the projectDeliverables

Confidential, Annandale, NJ

Software validation / Quality Assurance Analyst

Responsibilities:

• Responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phasesof computerized systems.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintainingcompliance to the Quality Policy and all other documented quality processes and procedures.
• Enforce the company’s Quality Standards and Procedures for Computerized Systems, as defined in theirgoverning Quality Management System.
• Implementing and enforcing company policies and procedures for software quality assurance directlycontributing to quality deliverables.
• Help implement risk-based System Validation, Process Validation, and Software Validation.
• Provide interpretation and guidance on various SDLC methodologies.
• Participate in department quality improvement initiatives and actively apply software QA methodologystandards.
• Directly support QA initiatives for planned and unplanned software releases.
• Create, maintain, summarize, review, and approve QA related-documentation against quality-documentattributes, including but not limited to good documentation practices, completeness, traceability, accuracy,coverage and testability of system requirements, software defect detection, compliance risk mitigation,change management, roles and responsibilities.
• Collaborate with Product and project management teams on system-related enhancements as well as issueresolution.
• Review business and technical designs, and other work products for new functionality/featuresand provide feedback as needed.

Confidential, MA

CSV Analyst

Responsibilities:

• The project involved upgrading the system LIMS as per cGMP compliance and 21CFR Part 11, and the database to support LIMS
• Developed Installation Qualification, Operational Qualification, and Performance Qualification Documentsbased on the User and Functional Requirement Specifications
• Post-Execution Review of the Executed Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ) Documents
• Developed Requirements Traceability Matrix (RTM) to trace the User and Functional Requirements to TestScripts in the IQ’s, OQ’s, and PQ’s.
• Address deviations using the Protocol Deviation Form and completed the Qualification Reports once theIQ’s, OQ’s, and PQ’s are Executed
• Authored the Validation Summary Report to capture the Developed Validation Protocols and verify that theAcceptance Criteria as established in the Validation Plan is met
• Participated in preparing and presenting weekly presentations for the progress of the project
• Participated in periodic review process and documented Periodical Evaluation Report.

Confidential, South Plainfield, NJ

Validation Analyst/ QA

Responsibilities:

• Prepared Validation protocols for Equipment Qualification
• Approved and reviewed standard operating procedures (SOP) for various processes and equipment’s.
• Validated laboratory equipment’s such as multicoaters, gas chromatograph’s, and spectrophotometer’s inQC Analytical & Microbiological Lab.
• Developed Validation Protocols, Summary reports for Validating QC laboratory equipment.
• Review and Approval of Intended Use, Validation Plan, Functional Requirement Specifications, System Configuration Specifications, System Design Specifications Documents, Installation Verification and Operational Testing, and Traceability Matrix.
• Post-Execution review of the Installation Verification and Operational Testing Document, which consists of Installation Verification and Operational Testing Forms.
• Operation Testing Forms captures testing of Operational Parameters Limits, 21 CFR Part 11, Alarm/ErrorMessages, Safety, Functional and Operational, Security, Loss of Utility, Data Backup and Restore, and Application Back up.
• Validating Microsoft Excel Workbooks/Worksheets used in the Manufacturing Processes (COTS Configured)
• Develop Trace Matrix and Verify whether the trace matrix reflects the traces to the correct test scripts

Confidential 

QA / Technical Writer

Responsibilities:

• Involved in the development of protocols and amending them as required.
• Responsible for documenting the defaults occurred during the execution of protocols.
• Responsible for maintaining and calibrating the equipment status.
• Monitored activities of validation procedures.
• Involved in training the team members and equipment operators.
• Responsible for approving the testing standards that are being used.
• Reviewing the validation documents and monitoring the SOPs that are being followed.
• Responsible for applying cGMP, GAMP as needed.
• Responsible for evaluating the test results and generating the validation reports.
• Monitoring and receiving the validation reports, batch records, risk assessment reports to facilitate the successful execution of project.