SUMMARY

• Validation analyst wif over 7 years of experience in FDA regulated environment specializing in computer systems validation and process validation. Hands on experience in preparing and documenting Validation Master Plan, Gap Analysis, SOP’s and Validation protocols. Knowledge of LIMS, AERS and EDMS. Experienced in all phases of Software development life cycle.
• Excellent understanding of the Software Development Lifecycle (SDLC) and Validation life cycle (VLC)
• Excellent knowledge of standard practices (cGLP, cGCP and cGMP), 21 CFR Part (11, 50, 56, 58, 210, 211, 820) and Remediation Plans
• Working Knowledge of 21CFR part 11 (Electronic records and Electronic signatures).
• Excellent understanding and implementation skills on GAMP 4 and GAMP 5.
• Expertise in documenting Validation Master Plan (VMP) and Validation summary report, Requirements Traceability Matrix (RTM)
• Played a major role in assessing risk and compliance issues for Data Migration activities and OQ re - execution and communicating the risk issues wif the IT and the management team.
• Expertise in developing, reviewing and approving Installation (IQ), operational (OQ) and Performance Qualification (PQ) validation Protocolas
• Experienced in documenting of User Requirements and Functional Requirements specifications.
• Experience in Technical Writing, Report Generation and Software Documentation.
• Expertise in preparation of Testing documents like Test plan, Test design specification and Test Summary report for executing test scripts according to the SOPs
• Experience in writing and executing User Acceptance tests (UAT).
• Experience in validating pharmaceutical equipment, systems, process and utilities.
• Expertise in calibrating and validating analytical instruments like HPLC, Plate Readers, Incubators, GC, Autoclaves, Ovens, ICP Mass Spectrophotometer and Lab Instruments (Conductivity meter, pH meter)
• Profound knowledge of LIMS and LIMS scripting, Adverse Event Reporting Systems (AERS) and responsible for writing Change Control Procedures for existing LIMS systems.
• Having functional and implementation knowledge of SAP Solution manager.
• Experience in Electronic Data Management System (EDMS) and Electronic Data Capture (ECR) applications.
• Experienced in preparing Quality Assurance Audits and Reviews.
• Experience in using testing tools like Quality Center, Win Runner, Load Runner and Test Director for Web and Client/Server applications.
• Excellent time management skills and ability to quickly analyze and solve complex problems.
• Ability to perform multiple tasks simultaneously and to prioritize work, goals and tasks per the divisional objectives.

TECHNICAL SKILLS:

Computer System Validation: 21 CFR part11 (Electronic records and signatures), 210 (cGMP in processing, production, packaging and holding of goods), 211 (cGMP in finished products), 820 (Quality system regulation), GxP, SDLC, Validation protocols (IQ, OQ, PQ, DQ), URS, FRS, QTP, Validation Master Plans, Test Scripts, SOP s, RTM, AERS, summary reports, executing test scripts for validation.Testing tools Winrunner, loadrunner, Quality Test professional (QTP), Quality center.

Change request tools: Test director.

Statistical tools: Minitab

Methodologies: Agile, Waterfall.

Language skills: C-language

Operating systems: UNIX/LINUS, Windows 95/98/2000/XP/Vista,Macintosh.

Microsoft Office tools: MS Word, MS Excel, MS PowerPoint, MS Access, Chemdraw, Visio.

PROFESSIONAL EXPERIENCE:

Confidential, Duluth, Georgia

Validation Engineer

Responsibilities:

• Prepared and maintained the Standard Operating Procedure (SOPs) and Validation Summary Report.
• Reviewed versions of Data Migration document and prepared a Data Migration Summary document.
• Testing software databases including data migration and load testing.
• Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance wif FDA regulations, particularly 21 CFR Part 11 including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Responsible for data migration and conversion activities such as extracting, transforming, migrating, validating and reconciliation of data. Provide guidance to internal IT key users to design and develop data loaders/templates to fit the business requirements.
• Created and executed test cases for new TrackWise modules (Internal and External Audits).
• Coordinated wif the system Analyst, Project manager and Business Analyst to set up the Pre- validation and validation Environment to execute the scripts.
• Developed Requirements Traceability Matrix (RTM) to track requirements and to align the work process.
• Involved in verifying and matching the executed and reviewed versions of Data Migration - Phase1document.
• Prepared Design Specification in the form of process flow diagrams using MS Visio.
• Developed FRS (Functional Requirement Specification) and URS (User Requirement Specification).
• Developed GAP analysis, Remediation Plan.
• Drafted SOP’s and trained users on these systems and the implications and impact of 21 CFR Part 11 compliant data systems on the day-to-day functions.
• Involved in preparing compliance report about the existing status of cGMP, cGCP, and cGLP.
• Regular interaction wif designers, developers and system analysts.

Confidential, Morris Plains, NJ

Validation Engineer

Responsibilities:

• Reviewed Business Requirements and prepared Validation Master Plan to implement LIMS
• Performed the role of Data migration consultant. Define and ensure dat data quality thresholds are met through active collaboration and review data quality assessments wif business users.
• Involved in development of OTC, SD, MM and PP modules.
• Recommended changes to support SAP system in compliance to company policies.
• Created, Reviewed and documented transaction codes for ASN, billing and order receipts
• Configured the system according to user requirements
• Documented all aspects of Computer System Validation in conformance wif 21 CFR Part 11 including validation protocols such as Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ)
• Assessed the risk involved in addition of new modules
• Preparing a Data Migration Summary Report stating the data migration activities taken place while loading the static data in the LIMS application.
• Analyzed Test Scripts to ensure compliance wif 21 CFR parts 11 wif respect to Audit Trail, Data Integrity and Data Security of the application.
• Develop and implement tools to validate Master Data loaded into the production system and effect corrections when necessary. Distill and distribute millions of records in the form of meaningful reports to internal groups based on relevance.
• Proactively review data structures in order to provide best practices for extracting, transforming and validating conversion data.
• Validated computer systems using cGMP, cGLP and cGCP guidelines
• Made Deviation and Failure Investigations for the deviations found in the system
• Prepared Deviation Report
• Conducted GAP Analysis to access the company’s current compliance status against FDA’s guidelines
• Drafted Remediation Plan for the project as part of a team

Confidential, Santa Clara, CA

Validation Analyst

Responsibilities:

• Used TrackWise to generate the change control number and manage the change control flow
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification documents of Siebel CRM
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Developed Validation plan (VP) to define validation strategies for Siebel CRM including Infrastructure Qualification and deployment.
• Responsible for reviewing the incomplete sections of the Data Migration - Phase1document from the system and updating the document as per the current configurations in the system.
• Involved in validating the TrackWise CAPA (Corrective Action Preventive Action) Business Workflow
• Validated the Integration of the CAPA Workflow wif 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.
• Reviewed the edited URS/FRS/DS documents as per the change request.
• Involved in periodic auditing of the change management systems to ensure dat the change management systems are in compliance wif SOP.
• Executed Black Box, Negative, Regression, and Integration &Security Tests as per the test plans and test scenarios
• Involved in Validation activities for releases wifin Siebel CRM.
• Reviewed and edited the URS/FRS/DS documents of Siebel CRM.
• Involved in Data Migration End-to-End testing including executing the test procedure and writing the Test Analysis Report for Data Migration End-to-End System Test.
• Involved in the Change Advisory Board (CAB) meetings to discuss the GxP/PDMA impact of new change requests and the compliance risk level associated wif the change.
• Involved in the discussions wif business and IT managers on the status of open change controls.
• Reviewed and approved the test execution scripts in Quality Center.
• Managed the testing process in Quality Center
• Ensured dat application is in compliance wif 21 CFR Part 11 and cGxP regulations.
• Ensured dat all the change controls are in compliance wif GxP/PDMA regulations before they are closed out.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).

Confidential

Validation Engineer

Responsibilities:

• Designed, Developed and Managed the QA process based on functional requirements.
• Coordinated wif the Senior Validation Engineer to write the Validation Master Plan.
• Developed and executed validation guidelines for testing the cGMP sensitive transactions.
• Developed Requirement Traceability Matrix (RTM) to track requirements during QA testing phase.
• Coordinated wif Systems Analyst and Network Administrator to make the server and machines qualify through complete Installation Qualification (IQ) and Operational Qualification (OQ) procedures.
• Performed Manual Testing of the application prior to automate testing using WinRunner.
• Performed GAP Analysis.
• Used Load Runner to perform Performance and Stress testing.
• Used Test Director for bug tracking and reporting, also followed up wif the development team to verify bug fixes and updated bug status.

Confidential

Validation Engineer/ Technical Writer

Responsibilities:

• Involved in gathering the User Requirements from the System Owners document for all the software components.
• Validated and developed Argus safety software so dat it was compliant wif ICH guidelines and also managed reported adverse events.
• Performed Global adverse TEMPeffect case data management and regulatory reporting to the industry using Argus safety
• Developed FRS (Functional Requirements Specification) and DS (Design Specification) from the URS (User Requirement Specification)
• Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Actively involved wif the application developers in developing the high level System Design Specifications (SDS) documents.
• Used MS Visio for pictorial representation of the Design Specifications and workflow of the process.
• Involved in documenting Vendor Assessment Report from a list of AERS suppliers.
• Developed Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Checked the modules of the application and used SQL queries to extract the data from database.
• Involved wif the development team to verify bug fixing and update bug report status using HP Quality Center.
• Responsible for writing change control SOP’s to comply wif 21 CFR Part 11 requirements.
• Developed test plans, test strategies, test scripts for validation testing
• Validated and developed Argus safety software so dat it was compliant wif ICH guidelines and also managed reported adverse events.
• Responsible for developing test protocols for audit trail, time stamp and electronic signature for the work flow of documents
• Prepared documentation for the various SOP .
• Involved in writing audit plans for the quality department
• Expertise in audits and assessments on documents and systems.