SUMMARY

• Over seven years of experience in extensive Equipment and Software Validation in Pharmaceutical industry and biomedical industry.
• Knowledge and competent in Quality system and standards for GxP’s (cGLPs, cGCPs and cGMPs),HIPAA requirements,21 CFR Part (11,50,210,211,820), HL7, Gap Analysis and Remediation Plans.
• Experience in reviewing and approving the Validation Documents including SOPs, IQs, OQs and PQs.
• Experience in performing risk assessment using the GAP Analysis, and GAMP 4 &GAMP 5 guidelines.
• Prepared, reviewed and approved procedures such as Backup and Recovery, Server Build, Anti - Virus, AssetManagement, Problem Management, Change Management, Patch and Release Management, PerformanceCapacity Management, Physical Access and Security, Training Administration, Server Decommission,Account Management and other procedures as applicable.
• Experience with Corrective Action and Preventive Action (CAPA) investigation to identify and evaluate the problem or non-conformance.
• Emphasis both on manual and automated testing through thorough understanding and knowledge of Validation Life Cycle and Software Development Life Cycle (SDLC)
• Expertise in using automated testing tools such as QTP (Quick Test Professional), Win Runner, Load Runner and Quality Center
• Experience working on GxP systems like LMS, Document Management Systems, LIMS and IT PMO.
• Hands on experience working with Test Management tools (HP ALM/Jira).
• Expertise in evaluating CSV risk assessments involved in the project in accordance with FDA compliance and experience on Defect Management.
• Facilitated requirements gathering sessions for IT projects related to implementation and/or enhancement of IT systems and applications.
• Excellent working knowledge of SAP, Electronic Data Management System-Aegis, Insight Publisher (electronic submissions), and Adverse Event Reporting System (AERS).
• Experience working with Trackwise to initiate and approve Validated System Change Requests (VSCR).
• Developed and carried out testing and validation processes in relation to prospective and retrospective validation efforts.
• Used TrackWise tool for quality management issues and tracking applications for Corrective and Preventive Action
• Successfully prepared and documented Change Control, Validation Master Plan (VMP),Validation Summary Report (VSR), and Requirement Traceability Matrix
• Expertise in technical writing of validation protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Validation Master Plan (VMP).
• Experience in GUI and Functionality, Load, Stress, Performance, Regression, Smoke and System/end to end testing
• Involved in Change Management process with respect to business process changes along with time stamps and approval processes.
• Designed Functional specification documents for RICEFW objects.
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
• Good understanding of various life cycle methodologies Water Fall and Agile and Agile Scrum.
• Implementation of Test Plans based on business requirements technical and specifications and interactions with Business and System Analysts.
• Involved in periodic auditing of the change management systems to ensure that the change management systems are in compliance with SOP. .
• Good knowledge of SOX working regulations.
• Excellent experience working with Documentum
• Proven efficient in working in both individual and team based environment
• Energetic self-starter with intellectual curiosity, excellent communication, technical and interpersonal skills.

TECHNICAL SKILLS

Computer System Validation: 21CFR (11,210,211 and 820), GAMP, cGxP, RTM, UR, SOP’s, Validation Protocol (IQ, OQ, PQ), GAP Analysis, Documentum (6.0 and 6.5).

Software Application: LIMS, Documentum, TrackWise, AERS, Data Transfer

Platform: Windows OS, MAC, UNIX

Database: MS SQL Server, Informix

SDLC: Waterfall and V Model, Agile and Agile Scrum.

Application: QTP, Load Runner and HPQC, HPALM.

Microsoft Office: (Word, Excel, Access, Front Page, Power Point, Photo editor).

Adobe: Adobe Acrobat 7-10, Adobe Photoshop

PROFESSIONAL EXPERIENCE

Confidential, NJ

LEAD QUALITY/ VALIDATION ANALYST

RESPONSIBILITIES:

• Lead and managed testing and validation activities in synchronization with project scope, schedule, business objectives, interpretation of applicable federal and international regulations, industry standards, internal control and guidelines that pertain to the validation of GxP system.
• Ensured Confidential ’s business targets are attained for Novartis engagement and put up a strong foundation for future business executing projects/programs with flawless delivery.
• Knowledge on testing and validation activities to be executed for existing and new project/program.
• Articulated testing and validation strategy, estimate efforts, resource planning, staffing, and resource utilization based on project demands.
• Built a team of professionals (onsite + offshore) with appropriate skills, attitudes and motivation.
• Understood the key components and principles of a computerized system validation and auditor expectations.
• Ensured the team understands how the CSV process fits into SDLC and the purpose of each validation deliverable. Determined the need of training and development needs of team members.
• Co-ordinated with customer team from various departments like Business, BUIT/IT, ISRM, RIM, Q-CSV in GxP Regulatory Assessment, Risk Assessment, validation Planning and validation Reporting.
• Ensured that project activities, validation deliverable and SDLC deliverable outlines in a compliance plan/validation plan are completed in accordance with define acceptance criteria and part of the validation package ( validation Plan, Risk Assessment, Protocols (IQ, OQ, PQ), validation Testing, Incident Report, RTM and validation summary Report).
• Ensured the change management and other standard operating procedure are being followed to maintain the application in validated state thought the system life cycle.
• Tracked and prepared the report of testing activities like testing results, test case coverage, defects encountered and their resolution status, etc.
• Collaborated with customer's internal and external partners, vendors, contractors, as required to meet dynamic needs of testing and validation resources.
• Participated in hiring process including conducting interviews and making hiring recommendations/ decisions.
• Ensured Confidential ’s internal capabilities/tools (like test case generation, automation framework, performance testing, electronic signature etc.) are evaluated based on client potential usage and are leverage to generate non-linear revenue.

Confidential, MA

VALIDATION ANALYST

RESPONSIBILITIES:

• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
• Performed Computer System Validation Assessment for Lab ware LIMS system to identify the validation deliverables for the project implementation regarding Documentum.
• Managed lab data effectively and timely using SDMS
• Involved in creation of Master Test Plan to strategize the test approach in various test cycles.
• Developed IQ/OQ/PQ Scripts.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Involved in the documentation for protocols, Operation Qualification (OQ) and Performance Qualification (PQ).
• Managed and organized requirement coverage, Test Case Management and Defect Management using and communicating between Team Lead, Developers to resolve the technical issues.
• Conducted Installation Qualification and documented the test results, deviations and corrective actions.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Involved in executing test scripts and documented test results in Test Summary Report.
• Created Traceability Matrix to keep track of all the requirements and test scripts.

Confidential, DE

VALIDATION CONSULTANT

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.
• Used Mercury Quality Center to organize and maintain a hierarchy of Test Cases, and defects in a web-enabled, shareable environment for Controls Vendor Audits.
• Created test procedures in Mercury Quality Center which was the test repository used for creating, storing and maintaining test cases.
• 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.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.
• 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, NJ

VALIDATION ANALYST

RESPONSIBILITIES:

• Created the Enhancement Assessment Matrix for the upgrade and categorized enhancements as Impact and No Impact items and Risk involved with implementing them.
• Created the User requirement specification for the upgrade.
• Created IQ, OQ, PQ Protocols.
• Created IQ, OQ, PQ Scripts and performed the dry run.
• Created OQ scripts which involved configuration and migration from one environment to other using Configuration Migratory Utility.
• Was involved in creating Risk Assessment document.
• Extensively worked on RICEF and the APS Manufacturing Order template BAPI, which allowed the business to configure orders created from an external planning system
• Created Validation Plan, Test Plan, Technical Architecture Specification Documents as per FDA and company standard.
• Involved in creation of new templates and forms to bring consistency in documentation for other projects too.
• Designed the Training Plan for the End users and Local Administrators for TrackWise.
• Was involved in managing (as a Test Coordinator) the testing efforts.
• Responsible for managing the discrepancies and maintaining the Discrepancy Log file
• Used Compliance wire to issue the training to the end user and local Administrator.
• Involved in revising the SOPs for different sites.
• Was involved in resolving issues with Sparta System faced during the upgrade.
• Involved in project scheduling and deciding Timelines for activities related to validation.
• Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases using QC
• Responsible to define test Requirements, run manual and automated tests, add and track defects using Mercury Quality Center
• Responsible for creating and executing Test Scripts in accordance with Good Testing Practices and Good Documentation Practices
• Designed Validation of Instrument Systems and ensured compliance with quality system requirements. Prepared protocols for following cGLP and cGMP procedures.
• Attended daily status meetings with Project management on testing updates.
• Involved in preparation of Validation Summary Report (VSR).

Confidential, CA

VALIDATION ENGINEER

RESPONSIBILITIES:

• Assisted in Test Method validation (TMV) for Equipment, and ancillary equipment/fixtures.
• Wrote, executed, and validated test method and procedures for Variable and Attribute Data
• Implemented new QEP (Quality Enhancement Plan).
• Performed Gap Analysis of current validation Status and formulation of requirements to resolve findings
• Reviewed process documentation and validation per industry guidelines, and according to project task list; specifically TMVs, SOPs, MVPs, PSWs, FMEAs, DFMEAs, DVs, DVP, DOEs, Control Plans, and BOMs.
• Re-executed Process validation of several medical devices, including TMVs IQ, OQ, PQ protocols and reports.

Confidential

VALDATION ASSOCIATE

RESPONSIBILITIES:

• Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.
• Co-ordinate and lead onsite-offshore activities from RICEF assignment till delivery
• Change control Procedure and Testing SOP’s.
• Gathered User Requirements from Business process owners.
• Reviewed URS (User Requirements Specification).
• Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification) documents.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with 21 CFR Part 11 and GxP FDA Compliance Regulations.
• Developed Test Plans, Test Cases using HP Quality Center.
• Was responsible for reviewing Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) test scripts.
• Coordinated UAT (User Acceptance Testing) for the application.
• Reviewed the Requirement Traceability Matrix (RTM).
• Was involved in reviewing Test Cases, Test Scripts and Test Summary Reports.
• Worked on Risk Assessment of the systems.
• Involved in deficiency investigations.
• Reviewed the Vendor Assessment Reports.
• Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Developed Test Cases for Functional UAT testing and Regression Testing.
• Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.
• Reviewed protocols for Audit Trail, time stamp and electronic signature for workflow of documents.
• Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.

Confidential 

VALIDATION CONSULTANT

RESPONSIBILITIES:

• DocumentedIQ, OQ, andPQfor different modules of Oracle Argus Safety, My Custom Reports and Oracle discoverer.
• Developed and maintainedValidation Master Plan.
• Ensured the process was in compliance with FDA rules and regulations.
• DevelopedStandardOperating Procedures (SOPs)based on the business requirements gathered forValidation Plan, Test scriptsandTest Procedure.
• Executed the IQ’s, OQ’s and PQ’s and coordinating simultaneously with the QA department
• Managed system upgrades, enhancements, and maintenance in a FDA regulated environment.
• Documented the Test Scripts and analyzed them to check for compliance with21 CFR part 11rules of FDA.
• Duties also included computer system validation and documentation of all materials during the testing phase of the project.
• PerformedGAP Analysisand also developed the correspondingRemediationplan
• Assisted in the implementation of software systems in conformance with regulatory requirements as they pertain to 21 CFR Part 11, Part 211 and GAMP 4.0 standards.
• Performed validation testing on TrackWise system which includes execution of OQ’s and PQ’s.