Professional 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,GAMP, 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 confirmance 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
• 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
• Operating Systems Windows NT/95/98/2000/XP/Vista/7, UNIX, Linux, Macintosh

WORK EXPERIENCE

Confidential

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.
• Applied GAMP 5 for all the computerized systems in the lab.
• TrackWise Configuration: Workflows, Configuration forms, User and Person creation, creating Process Projects, Divisions ,User Groups, membership, Default value classes, dependent classes, Required and Selection fields, Group Categories including VGC's, defining States and PR Tasks, configuration of System Flags, Co-ordinator configuration, automated reports handling, trending requirements, Configuration Migration from one environment to another configuring Crystal Report Server RAS to interface with Team Access and various other configuration activities.
• Assisted in documentation and development of SOPs for TrackWise
• 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 for TrackWise .
• Drafted IQ test cases for verifying configuration of TrackWise workflows.
• 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
• Followed GAMP to test the GxP systems.
• Performed user acceptance testing to the check the various functionalities of LIMS.
• Developed test scenarios for testing workflow paths in TrackWise
• 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

Applications: EDMS / IRMS / Documentum / Siebel CRM

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 includes 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.
• Reviewed and tested IBM Cognos reporting functionality for IRMS6.0.
• 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
• Followed GAMP to test the GxP systems.
• Retrieved the legacy systems following GAMP
• 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

Applications: CCMS / Medical Device TrackWise

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

Application: AERS

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