SUMMARY

• A Versatile validation professional with 7+ years of diversified experience in the Pharmaceutical and Biotechnology Industries working as a Validation Analysts / QA Consultant focusing on Computer System Validation and Equipment Validation.
• Strong understanding of 21 CFR part 11 drug GxP requirements including electronic records, electronic signatures, system validation strategies and Documentation
• Experience in creating developing SOP's, Validation Master Plans (VMP), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), 21 CFR Part 11 Assessment and Validation Summary Reports (VSR).
• Write technical documentation and update existing documentation such as functional specifications, design specifications.
• Experience in documenting and reviewing all aspects of the Computer Systems Validation (CSV) lifecycle for Quality Assurance.
• Adept at using both manual and automated testing tools to troubleshoot systems, integration, user acceptance, positive and negative, functionality, object, and regression.
• Excellent documentation skills in compliance with Good Documentation Practices (GDP).
• Good understanding and Practical knowledge on GAMP 4 & 5 regulations.
• Maintained and updated traceability matrix.
• Reviewed post executed test scripts and created Validation summary report.
• 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.
• Experience in Corrective Action Prevention Action (CAPA), Change Control Process, and Document Management Process.
• Hands on experience in documents review and approvals in QA aspects.
• Trouble shoot equipment problems, identified the need for new equipment and made modifications to the existing equipment to optimize and reduce process cycle time.
• Tracked quality deliverables, project progress vs. schedule; communicated progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
• Prepared training documentation for the various SOP training.
• Excellent organizational, interpersonal, written and oral communication skills.
• Proficient in working individually and as a part of a team.

TECHNICAL SKILLS

Life Sciences: 21 CFR Part 11, cGxP (cGMP, cGDP, cGLP), GAMP, IQ, OQ, PQ, RTM, SOP, Summary Reports, Audit Trails

Testing and Tracking Tools: Win Runner, Load Runner, Test TrackPro

Languages: C, C++, FORTRAN, VB script, TSL

Operating Systems: Windows 95/98/2000/ NT, UNIX

Databases: SQL, Oracle 8.1, Microsoft Access

Analytical software: SQL* LIMS 4.0

Scientific Software: MATLAB, MAPLE, ChemCAD, SAS

Other Tools: MS Office, MS Visio

PROFESSIONAL EXPERIENCE

Confidential, Waltham, MA

Validation Tester/Analyst

Responsibilities:

• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing
• Developed test plans and test cases for procure to pay, order to cash and MM
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Implemented cGxP (GMP, GLP, GCP) and GAMP4 guidelines in the systems.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Involved in executing the test scripts to test the interface between SAP and LIMS system.
• Executed and reviewed the test scripts for new SAP transactions, Customized transactions, tables.
• Developed the Test Scripts to generate the Audit Trail reports to verify the creation, modifications to the records are captured in audit trail table logs.
• Review and approve change control documentation.
• Use HPQC to review and approve test cases, results, and defects.
• Provide guidance and training to ITS department on the development and execution of validation plans.
• Provide expertise in review of all deliverables across the project lifecycle.
• Ensure documentation meets quality standards, applicable regulatory compliance and company guidelines.
• Monitor and Advise on quality of all deliverables and report to management.
• Review and approve Post execution of OQ test cases and defects.

Confidential, Phoenix

Validation Engineer

Responsibilities:

• Performed gap assessment and developed remediation plan.
• Analysed User Requirements and Regulatory Requirements for the Computer Systems.
• Provided technical, quality, and engineering support for Equipment qualification and Computer System Validation - Manufacturing systems.
• Reviewed validation deliverables (VP, VSR, IU, TM, IVOT, IVPR, IVTP, IQ, OQ, FRS, CAF) and identified boundary and invalid entry conditions.
• Oversaw and led the execution of validation protocols, investigated and resolved deviations, Non-Conformances (NC) during execution of protocols
• Tracked quality deliverables, project progress vs. schedule; Communicated progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule
• Technical Writer / Data Entry in DMS and Complaints using Track Wise System.
• Drafted and reviewed test scripts for quantum test stands.
• Implemented GDP and trained the team.
• Maintained and updated traceability matrix.
• Reviewed post executed test scripts and created VSR.
• Authored various documents (IU, VP, VSR, Test plans and protocols).
• Participated in project status meetings and provided status updates.
• Gathered and updated functional requirements according to IU and test results.

Confidential, Vernon Hills IL

Validation Engineer

Responsibilities:

• Designed, implemented and validated 21 CFR Part 11 compliance strategies for LIMS.
• Played a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.
• Provided system support and configuration support required to maintain quality management solution.
• Wrote the technical specifications for new business processes, updated technical specs for improvement and generated validation documentation.
• Authored and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification(OQ) and Performance Qualification protocols for the LIMS application.
• Analysed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HPALM and executed them. Executed validation test cases based upon system requirement and FDA standards.
• Performed functionality testing for the entire application. Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved.
• Developed test cases and test scripts to perform regression testing. Tracked and closed the defects using HP ALM.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Maintained the Requirement Traceability Matrix (RTM).
• Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Involved in writing the Computer System Validation Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities.

Environment: HP Quality Centre, MS Office, 21 CFR Part 11, cGxP, ARIS-G

Confidential, NJ

Validation Analyst

Responsibilities:

• The project involved major upgrade and validation of AERS (ARIS Global) and developed relevant compliance deliverables as per 21 CFR Part 11 and GxP requirements.
• Created and revised validation documents for the entire system life cycle process.
• Reviewed the User Requirements Specification and Functional Specifications from the compliance perspective to ensure that the regulatory requirements are stated and testable.
• Participated throughout different phases of the SDLC, used Documentum as an Electronic Document Management System to store and maintain the project and validation related deliverables.
• Authored and reviewed the validation lifecycle deliverables such as Requirement Specifications (User and Functional), Configuration Specifications, Validation Plan and Testing documents and Summary Report.
• Responsible to define Validation Strategy, Roles and Responsibilities, Required documents and acceptance criteria in Validation Plan.
• Authored and executed various test cases for different phases of the test cycle such as Installation Qualification, System/Functional Qualification and User Acceptance Testing for validating ARIS Global.
• Performed functionality testing for various modules of Adverse Event Reporting System (ARIS Global) to verify that the data management and adverse drug reporting is according to performance standards.
• Member of the Change Control Team, worked as Validation Support personnel to assess and develop the testing strategy to test the changes, work around for known issues and bugs.
• Participated in Project Change Control meetings and discussed Enhancement and Modification Requests
• Worked with Business SMEs to document the Test Plan that contains test scripts, test cases, test data and expected results for the User Acceptance testing (UAT).
• Performed Periodic Reviews, 21 CFR Part 11 GAP analysis on Requirements to identify error or omissions in the requirement specifications and to maintain system in its validated state.
• Prepared and Maintained Requirement Traceability Matrix for mapping User Requirements to Functional Requirements and their testing coverage.
• Ensured and tested that the system maintains the Audit Trials that keep details about the event, users and complete time and date stamped record for all the records.
• Used HP Quality Center to draft and executed Test Case and Tracked the Defects using defect management module.
• Documented, reviewed and updated training materials, user manuals, SOPs and Work Instructions for system use and maintenance.

Confidential

Process Validation Engineer

Responsibilities:

• Created Test Plan, Test Strategy, Organization Plan, Test estimation & Test Cases.
• Interacted with developers, system engineers, and testing teams to identify applications defects.
• Conducted reviews and walkthrough meetings for process improvisation using Agile Methodology.
• Involved in writing reusable scripts and reusable actions in QTP and parameterizing data to run automation tests on different data items.
• Extensively used regression testing, system testing and Black box testing methodologies.
• Worked with developers and requirements analysts to define test scenarios and ensure that test requirements are correct and complete
• Worked on conversion of manual integration tests into automated tests using QTP.
• Participated in User Acceptance testing (UAT) and involved in writing and executing test cases, documented defects, resolved defects and signed off on QA.
• Extensive regression testing of new code in pre and post deployment environments. Developed Load runner test scripts according to test specification/requirements.
• Performed Load/Performance/Stress test using load runner with Web (HTTP/HTML) protocol.

Confidential 

Quality Assurance

Responsibilities:

• Created flowcharts using MS Visio to understand the flow of application and provide an overview of the software system to be validated.
• Designed a spreadsheet categorizing events by product and automate updates.
• Responsible for authoring Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Involved in documenting Vendor Assessment Report from a list of AERS suppliers.
• Customize reports synchronizing the paper and electronic versions of the forms.
• Performed system and UAT testing for all the functionalities of the application and documented results based on business requirements.
• Developed Requirement Traceability Matrix (RTM) to track changing requirements.
• Attended weekly meetings with development team to discuss progress of milestones and dependencies.

Environment: HP Quality Centre, MS Office, 21 CFR Part 11, cGxP, DMS FirstDoc, ISI-RSS, SPL.