SPECIALIZED IN:

Computer System Validation, Technical Writing, EDMS, ETQ, TrackWise.

SUMMARY:

• 7 years of Experience as a Computer System Validation Engineer within the Biomedical and Pharmaceutical industries with experience in testing and leading teams for custom solutions in the cross functional areas
• Well - versed with validation of systems like Track Wise, EtQ (EQMS), Adverse Event Reporting Systems (AERS), Documentum, spreadsheets, Clinical Trial Management Systems(CTMS), Laboratory and Information Management Systems (LIMS).
• Expert in writing and executing test requirements, test plans, test cases, test scenarios and test scripts
• Vast experience in performing validations in a cGxP (GMP, GLP, GCP) environment
• Strong cognition in Software Development Life Cycle (SDLC) and test methodologies
• Well educated in FDA 21 CFR Part 11, 210, 211, 820 and general principles of Software Validation Life Cycle
• Experienced in authoring Intended use document, CCD, URS, FRS, Test scripts, Deviation reports, Test summary reports, Traceability Matrix, Gap assessment report and other deliverables required to ensure that a computer system is validated
• Highly skilled in Writing Validation Protocols such as IQ, OQ, PQ’s and Validation Master Plan (VMP)
• Good knowledge in performing Functionality testing, Integration testing, Back end testing, White Box testing, Black Box testing, User Acceptance testing (UAT)and Sanity testing and Regression testing
• Good knowledge in preparation of deliverables, business process design and workflow, business requirement documents, detailed business functional and non functional specifications, use cases and test cases
• Excellent hands on experience in performing Automated and Manual Testing using different testing tools
• Proficient in MS Office Suite and Visio
• Good knowledge of GAMP 4 & GAMP 5 and all relevant FDA guidelines

SKILL:

Validation: 21 CFR part 11, Part 210, Part 211 and Part820), Validation Protocols (IQs, OQs, PQs), cGxP (GLP, GMP, GCP, GDP), SOPs, LIMS (CTDMS, SDTM), AERS, Audit Trials, Gap Analysis, Remediation

Bug reporting Tools: HP Quality Center

Compliance Management: Track wise

Languages: SQL, HTML, C, C++

Databases: Oracle 10g

EDMS,ECMS: Documentum, Live Link

Front Office: MS Office, MS Visio, MS Project

PROFESSIONAL EXPERIENCE:

Confidential, Fort Washington, PA

Validation Analyst /Technical Writer

Responsibilities:

• My project involved in developing protocols, validating Enterprise quality management systemsoftware that helps to regulate the companies to quickly and confidently validate the companies ETQ environment.
• Supported the IT CSV team of QSE 4 and 18 in defect reporting, defect tracking.
• Authored the VMP and test Scripts of ST and UAT of ETQ system.
• Created, reviewed and executed the test plans, test cases and test conditions for ETQ symphony.
• Designed technical documents like User requirement specifications and Functional requirement specifications by collaborating with respective authorized team members.
• Documented the Test Defect Reports where applicable during the execution of test scripts and closed test defect reports (TDRS).
• Responsible for writing IQ/OQ/PQs for the EtQ application and also participated in audit prepares for third party and FDA audits.
• Coordinated with the team in analyzing, identifying, prioritizing and managing software defects and effectively worked with developers in fixing, verifying, and closing defects.
• Generated and worked on the CAPA, triggered from the test defects reported.
• Developed procedures including flow charts for implementing corrective and preventative actions.
• Actively participated in Project meetings and discussions to ensure all project deadlines are met.
• Reviewed and maintained test defect status reports, defect logs.
• Reviewed test cases and scripts to ensure that documentation was as per the FDA regulations.
• Coordinated with System Analysts and Project Manager to set up the Pre-Validation and Validation environment to execute scripts.
• Developed documentation for all aspects of the Computer System Validation Lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan, Traceability Matrix, Protocols - Installation qualification ( IQ) and Operational qualification (OQ), Performance Qualification (PQ) and Validation Reports.
• Developed the system training Work Instructions in accordance with business process and system requirements.
• Involved in performing the GAP Analysis, Root Cause Analysis of the system and develop Remediation Plan

Confidential, Webster Groves, MO

Validation Engineer / Technical Writer

Responsibilities:

• Reviewed the user requirements document and prepared the detailed Test Plan and Test Criteria for validation of CAPA module and Supplier Quality Management System (TrackWise).
• Authored risk assessment document against the user requirements and corresponding functional requirements.
• Authored and maintained Requirements Traceability Matrix (RTM) to track requirements to the test scripts.
• Involved in all aspects of the computer systems validation lifecycle, to comply with FDA regulations (21 CFR, part 11 and 21 CFR Part 820).
• Authored VMP/VSD, IQ, OQ and UAT protocols.
• Authored and executed an interface performance script by adding 100 inspection lots in to a single record in TrackWise.
• Logged in issues identified in the interface and verified the technical fixes.
• Quality reviewed SAP interface ST scripts and UAT scripts.
• Coordinated with System Analysts and Project Manager to set up the Pre-Validation and Validation environment to author and execute Test scripts.
• Developed the test Scripts for system testing (OQ) and UAT.
• Wrote and reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.
• Drafted SOPs and explain in simple language scientific and technical ideas that are difficult for the average reader to understand.
• Documented all materials during the testing phase of the project.
• Actively participated in Project meetings and discussions
• Trained users on these systems and the implications and impact of 21 CFR Part 11 compliant data systems on day to day functions.
• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments.
• Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.

Confidential, Pittsburgh, PA

Software Validation Consultant

Responsibilities:

• Involved in Validation of EDMS Documentum, AERS and spreadsheet systems for client.
• Responsible for data migration and data verification in migrating data from old system to the newly installed computer system.
• Involved in review of validation plans, requirements by senior managers from the business and development teams.
• Responsible for making systems compliant to 21 CFR Part 11.
• Generated Validation Master Plan (VMP), IQ, OQ protocols, and test scripts for system testing.
• Authored UAT scripts and trained users in conducting UAT testing of computer systems.
• Analyzed Test Scripts to ensure compliance with 21 CFR part 11 with respect to Audit Trail, Data Integrity and Data Security of the application.
• Engaged in tracking requirements and managing test methods using Mercury Quality Center and authoring Deviation reports.
• Involved in the development of strategy for back up and disaster recovery.
• Tested in all platforms under all machine specifications to report the Standard operating procedures.
• Developed the validation strategy for Spreadsheets and performed the validation accordingly.
• Utilized Documentum and created documentation in all phases of the SDLC
• Created and maintained the Requirement Traceability Matrix (RTM) for the application.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.

Confidential, Fort Collins, CO

Validation Analyst

Responsibilities:

• Worked on validating customized CTMS (Allegro) application that was designed to manage clinical data from the clinical trials.
• Analyzed specifications and business requirements and developed VMP, test cases, test scripts.
• Developed documentation for all aspects of the Computer System Validation Lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocols - Installation qualification (IQ) and Operational qualification (OQ).
• Strategized project scoping and specifications documents. Responsible for the communication of the project roadmap.
• Conducted UAT (User Acceptance Test) to make sure that all the user requirements are catered by the application and constantly redesigned the system to increase its user friendless for the clients.
• Coordinated daily team activities to ensure project schedule remains on target.
• Prepared routine reports on the progress of assigned tasks.
• Developed Test Cases to perform GUI and Functionality testing using Quick Test Professional.
• Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects (created by QA Testers) to the developers using the Quality Center.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Performed Integration, Positive and Negative testing of the system.
• Maintained the Requirements Traceability Matrix (RTM) and mapped the modified test cases as per the new requirements.

Confidential, Aurora, IL

Validation Analyst

Responsibilities:

• Performed Validation Testing on the application in accordance with 21 CFR Part 11, Part 211
• Implemented and developed a standard process for using Electronic Signatures on all electronic-document transfers using the 21 CFR part 11 standards LIMS.
• Maintained existing System & Integration Test Plan according to the Standard Operating Procedures (SOPs) and VSD.
• Involved in evaluating the 21CFR part 11 requirements and creating a check matrix for the same.
• Developed Master Test Plan and Summary Reports for SAP Implementation.
• Assisted the camp Validation group in the development of GMP Quality Systems documentation including Standard Operating Procedures (SOPs), change controls and Re-Validation documents for failing systems.
• Responsible for writing SOPs, IQ/OQ/PQs for LIMS application.
• Performed Validation Testing on the application in accordance with 21 CFR Part 11.
• Validating processes in cGMP environment as per FDA guidelines.
• Performed testing according to SOP’S, assured all Validation documents are in compliance with cGXP regulations.