SUMMARY

• Validation analyst with 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 teh 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 teh risk issues with teh IT and teh 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 teh 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 teh 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 teh 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 teh computer system validation lifecycle, in accordance with 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 teh business requirements.
• Created and executed test cases for new TrackWise modules (Internal and External Audits).
• Coordinated with teh system Analyst, Project manager and Business Analyst to set up teh Pre- validation and validation Environment to execute teh scripts.
• Developed Requirements Traceability Matrix (RTM) to track requirements and to align teh work process.
• Involved in verifying and matching teh executed and reviewed versions of Data Migration - Phase1document.
• Prepared Design Specification in teh 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 teh implications and impact of 21 CFR Part 11 compliant data systems on teh day-to-day functions.
• Involved in preparing compliance report about teh existing status of cGMP, cGCP, and cGLP.
• Regular interaction with designers, developers and system analysts.

Confidential, Morris Plains, NJ

Validation Engineer

Responsibilities:

• Reviewed Business Requirements and prepared Validation Master Plan to implement LIMS
• Performed teh role of Data migration consultant. Define and ensure that data quality thresholds are met through active collaboration and review data quality assessments with 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 teh system according to user requirements
• Documented all aspects of Computer System Validation in conformance with 21 CFR Part 11 including validation protocols such as Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ)
• Assessed teh risk involved in addition of new modules
• Preparing a Data Migration Summary Report stating teh data migration activities taken place while loading teh static data in teh LIMS application.
• Analyzed Test Scripts to ensure compliance with 21 CFR parts 11 with respect to Audit Trail, Data Integrity and Data Security of teh application.
• Develop and implement tools to validate Master Data loaded into teh production system and affect corrections when necessary. Distill and distribute millions of records in teh 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 teh deviations found in teh system
• Prepared Deviation Report
• Conducted GAP Analysis to access teh company’s current compliance status against FDA’s guidelines
• Drafted Remediation Plan for teh project as part of a team

Confidential, Santa Clara, CA

Validation Analyst

Responsibilities:

• Used TrackWise to generate teh change control number and manage teh 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 teh incomplete sections of teh Data Migration - Phase1document from teh system and updating teh document as per teh current configurations in teh system.
• Involved in validating teh TrackWise CAPA (Corrective Action Preventive Action) Business Workflow
• Validated teh Integration of teh CAPA Workflow with teh other business workflows and teh interfaces for teh TrackWise workflow.
• Developed Traceability Matrix to track teh requirements during teh 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 teh edited URS/FRS/DS documents as per teh change request.
• Involved in periodic auditing of teh change management systems to ensure that teh change management systems are in compliance with SOP.
• Executed Black Box, Negative, Regression, and Integration &Security Tests as per teh test plans and test scenarios
• Involved in Validation activities for releases within Siebel CRM.
• Reviewed and edited teh URS/FRS/DS documents of Siebel CRM.
• Involved in Data Migration End-to-End testing including executing teh test procedure and writing teh Test Analysis Report for Data Migration End-to-End System Test.
• Involved in teh Change Advisory Board (CAB) meetings to discuss teh GxP/PDMA impact of new change requests and teh compliance risk level associated with teh change.
• Involved in teh discussions with business and IT managers on teh status of open change controls.
• Reviewed and approved teh test execution scripts in Quality Center.
• Managed teh testing process in Quality Center
• Ensured that application is in compliance with 21 CFR Part 11 and cGxP regulations.
• Ensured that all teh change controls are in compliance with 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 teh QA process based on functional requirements.
• Coordinated with teh Senior Validation Engineer to write teh Validation Master Plan.
• Developed and executed validation guidelines for testing teh cGMP sensitive transactions.
• Developed Requirement Traceability Matrix (RTM) to track requirements during QA testing phase.
• Coordinated with Systems Analyst and Network Administrator to make teh server and machines qualify through complete Installation Qualification (IQ) and Operational Qualification (OQ) procedures.
• Performed Manual Testing of teh 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 with teh development team to verify bug fixes and updated bug status.

Confidential

Validation Engineer/ Technical Writer

Responsibilities:

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