SUMMARY

• Over 7 years of experience in Technical Writing, Computer System Validation and Quality Assurance.
• Strong understanding of 21 CFR Part 11 drug cGxP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• In depth knowledge of GxP’s (GMP, GLP and GCP)
• Implemented Trackwise as a complete end to end solution to address the implementation of Product Complaints Handling, Investigation, (Food and Drug Administration) reporting, Risk Assessment, Trending and CAPA (Corrective & Preventive Action).
• Hands on experience working with Siebel CRM, Argus Safety 6.0 and IRMS.
• Good experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V - shape and Agile models
• Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulations.
• Comprehensive knowledge and extensive experience in preparing and reviewing Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Proficient in developing Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards
• Good experience of performing Gap analysis and preparing Remediation Plan.
• Good experience in writing Risk Assessment, Deviation report, Discrepancy report
• Experience in handling Analytical instruments like the HPLC, GC, GC-MS, LC-MS,ICP-MS and use of this knowledge in LIMS application
• Skilled in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations.
• Experience with Laboratory Information Management System (LIMS), Adverse Events Reporting Systems (AERS), Change Control Management System and Enterprise Document Management System (EDMS).
• Aptitude in System testing performed manual testing and automated testing. Proficient with Excel to manage different testing and data segregation activities.
• Good Knowledge of MS-Project, HP Quality Center, MS Visio and Documentum.
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.

TECHNICAL SKILLS

Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ RTM, SOPs, Summary Reports, Audit Trails, LIMS, CDMS

Testing Tools: HP Quality Center

SDLC: Waterfall, V-Model, Agile

Business tools: MS Office (Word, Excel, Power Point, Access, Visio), Trackwise 7.0 Siebel CRM, Argus Safety 6.0, IRMS and Documentum

Database tools: Oracle 10g, SAS 9.1, Open Clinical v3.0.4.2, Oracle Clinical v4.5.1 Oracle Clinical v4.5.3, SAP

Operating Systems: Windows NT/95/98/2000/XP/Vista/7, UNIX, Linux, Macintosh

PROFESSIONAL EXPERIENCE

Confidential, OH

Validation Analyst

Responsibilities:

• Customized and validated different components of the LIMS modules.
• Acquired and documented the business requirements.
• Prepared Validation Master Plan (VMP) for validating LIMS.
• Assisted in documentation and development of SOP.
• Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification.
• Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
• Developed OQ and PQ test cases.
• Drafted IQ test cases for verifying configuration.
• Developed and reviewed test scripts and test cases for automated and regression testing.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.
• Generated Validation Summary Report to summarize and document all validation activities
• Developed and reviewed Standard Operating Procedures (SOPs), Requirement Traceability Matrix and Work Instruction for various functionalities of the system.
• Used Defect Management grid of Quality Center in logging and analyzing issues.
• Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11.
• Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
• Performed user acceptance testing to the check the various functionalities of LIMS.
• Developed test scenarios for testing workflow paths in Trackwise.
• Executed test cases to verify trackwise functions, Workflow, Queries, Scope, End-End flow Approvals, permissions and Reports.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Conducted GAP analysis and prepared Remediation Plan.
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Confidential, Westbury, NY

Validation Analyst

Responsibilities:

• Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows
• Reviewed and updated end to end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures
• Involved in the complete validation activities CPS(Cardio Pulmonary Suite) software
• Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.
• Created and Reviewed several Change Controls for Quality validation plan, Risk Analysis Plan, IQ, OQ, PQ Protocols.
• Developed flowchart model of OQ workflows in MS Visio.
• Developed IQ, OQ, PQ protocols, Reviewed and executed them.
• Actively participated in the discussions during the configuration index and code review development
• Involved in periodic auditing of the change management systems to ensure that the change management systems are in compliance with SOP.
• Wrote the OQ,PQ Test case Issues in the Test Track Pro and Actively participated in discussion with the validation lead regarding the issues.
• Implemented testing methodologies, strategies and Software Development Life Cycle (SDLC)
• Managed the overall protocol execution process including resource management, scheduling/timeline management, incident management, and status reporting.
• Reviewed and edited URS documents as per the changes requested by the users during the project
• Created Risk assessment and Quality validation plan for the whole project.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in Application life cycle Management tool (ALM).
• Wrote test cases and maintained traceability matrix and wrote the defects in Application life cycle Management tool (ALM)
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Performed Performance Qualification (Such as Load/Stress, Volume and Response Time) and User Acceptance Tests (UAT) and also documented them.
• Involved in the development of the Information Protection and Risk Management assessment
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• Excellent knowledge of 21 CFR Part 11.
• Implemented cGxP’s (GMP, GLP, GCP) and GAMP5 guidelines in the systems.

Confidential, VA

Validation Engineer/Technical writer

Responsibilities:

• As a member of Computer Systems Validation team, responsible for documenting and reviewing all the validation deliverables within Siebel CRM.
• Performed regulatory and risk assessment of the computer systems.
• Used Documentum for storing the files.
• Authored VMP (Validation Master Plan) with risk based approach for validation.
• Responsible for developing, analyzing and reviewing validation deliverables like User Requirement specification and Functional requirement Specification of Siebel CRM.
• Responsibilities also include system qualification assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts of Siebel CRM.
• Responsible to get QA approval for validation deliverables and Vendor Audit.
• Developed Performance Qualification for Citrix based tool MIRS - IRMS.
• Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.
• Assisted in documentation and development of SOPs for IRMS 6.0 application.
• Designed, developed and implemented Test Plans using the detailed business requirements document.
• Understood data mappings and Created Test Cases and procedures.
• Responsible for mapping of IQ to Design Specification, OQ to Functional Specification and PQ to URS.
• Communicated validation approach and requirements to team and business owner.
• Maintained the Traceability Matrix between Requirements, Test cases and Defects.
• Extensively involved in Defect tracking, reviewing and analyzing and reporting test result using HP Quality Center.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in QC and reported the defects.
• Performed change control by assessing proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
• Conducted GAP analysis and prepared Remediation Plan.
• Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.
• Critically review and provide support for validation sections of regulatory submissions.
• Made sure all the documentation and records met 21 CFR Part 11 requirements.
• Submitting daily and weekly status reports to the manager and performed timely escalations to the management.

Confidential, San Antonio, Texas

Validation Analyst/Tester

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• 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.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Performed black box testing, positive testing, negative testing, front end testing and regression testing.
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Authored and reviewed Requirement Traceability Matrix (RTM).
• Developed applicable test cases for integration test, system test and acceptance test.
• Defects are tracked while processing testing and reported using HP QUALITY CENTER and paper based manual testing.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).

Confidential

Test Engineer

Responsibilities:

• Performed User and Business Requirements analysis to prepare Validation Master Plan.
• Performed Global adverse effect case data management and regulatory reporting to the industry using Argus safety.
• Established operating requirements and conducted tests to assure it is operating under normal and worst case.
• Performed Integration, Positive and Negative Testing of the application.
• Reviewed IQs, OQs, and PQs and documented results in compliance with FDA regulations.
• Performed GAP Analysis and developed Remediation Plans.
• Performed System testing and documented results as part of IQs, OQs and PQs.
• Updated and Maintained Required Traceability Matrix (RTM) as per the changing requirements.
• Performed GUI and functionality testing using QTP.
• Developed Validation Summary Report (VSR).
• Ensured validation documentation for compliance with cGxP.

Confidential

Validation Engineer

Responsibilities:

• Using backward/forward tracing of requirements and finding source using Requirement Traceability Matrix (RTM) for the application.
• Wrote documents for reports that can be queried by type of adverse event, disease and principle investigator.
• Wrote SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11 and GLP requirements.
• Developed Test plan and written several test scripts for validation testing.
• Wrote GAP Analysis report and Remediation Plan document.
• Reviewed and Documented IQ/OQ/PQ protocols.
• Performed Load Testing, Black Box Testing, GUI Testing and Functionality Testing for the entire application.
• Developed Test Cases and Test Scripts to perform regression testing using Win Runner.