SUMMARY:

• Over 7 years of diversified experience in Validation Methodologies, Technical Writing and Quality Assurance in Pharmaceutical Industry with a strong background in performing Computer System Validation and Software Development
• In depth knowledge of FDA regulations 21 CFR Part 11 and 21 CFR Part 820
• Good knowledge in GAMP4 and GAMP5 practices.
• Experience in validation of Quality systems like Application Server, Disaster Recovery system, Back Up Server, Supplier Audit Database and Controlled Spread sheet.
• Excellent experience in validating wide variety of applications and infrastructure - Business Intelligence Reports, Argus Safety, SAP, Excel spreadsheets, Electronic Document Management System (Documentum), LIMS, and AERS
• Experience in configuring, testing, administering and providing overall system implementation setup of Trackwise, IRMS and Siebel CRMS
• Experience with entire life cycle of Computer Systems Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment (VA) and System Design Specifications (SDS).
• Experience in developing protocols, Executing tests and Constructing Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies
• Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Front end testing.
• Good experience in using automation tools like QTP, WinRunner, Load Runner & Rational Suite and in designing and development of queries using SQL, PL/SQL.
• Expert in using Quality Center for managing tests and defects.
• Experience in Validation Procedures, technical writing for systems in compliance with cGMP, GAMP, cGLP, and cGCPs.
• Experience in writing and reviewing Computer System Validation Plan/Remediation.
• Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).
• Experience in writing Risk Analysis, Gap Analysis, and CAPA documents
• Developed comprehensive Test Summary Report and Test Cases
• Extensive Experience in working with MS Visio, PowerPoint, Word and Excel.
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.
• Strong analytical presentation with quick assessment & problem solving approach.

TECHNICAL EXPERIENCE:

Validation: LIMS (IQ/OQ/PQ) Protocols, FDA Regulations, 21 CFR part 11, GAP Analysis, GxP (cGMP, GCP, GLP, GDP) Environments, VMP, RTM, SOP, Audit Trails.

Operating System: WIN NT/2000/XP/7, Mac OS 9, Mac OS X, Linux

ToolsTools: MS Visio, MS Project, MS Office, Documentum, Mercury Win Runner/ Load Runner, TrackWise, Argus safety, IRMS, Siebel CRMS

DatabasesDatabases: PL/SQL, MS SQL, MS Excel, Oracle

Bug Tracking and Reporting: Mercury Test Director, HP Quality Center

WORK EXPERIENCE

Confidential, Madison, WI

Validation Lead

Responsibilities:

• Leaded a team of 14 members for end to end validation on 51 different tools used in Medical Device development on time and within teh allotted budget.
• Validated tools including Document Management Systems, Signal Processing Tools, Circuit Design Tools, Code Compiling Tools, Defect Tracking tools used in Medical Device Development
• Validated teh tools based on Windows 7 and Linux Operating systems (Ubuntu and Debian Lenny).
• Performed Risk Assessment for different tools following GAMP5 procedures
• Documented teh User Requirement Specifications and Design Specifications for all teh tools used in development of Medical Devices
• Trained teh team regarding teh intended use of teh tool
• Responsible for writing teh Validation Plan
• Made sure that teh team adheres to teh guidelines mentioned in teh SOP and training manuals.
• Coordinated teh team members and held daily meetings for TEMPeffective communication of status of teh project
• Involved in creating System operational and Administration SOP’s.
• Analyzed Test Scripts to check if it TEMPhas covered all teh functionalities.
• Responsible for reviewing and executing IQ/OQ/PQ test scripts.
• Responsible for writing teh Validation Report that also includes Traceability Matrix, Anomalies and Remediation Plan
• Reviewed all teh Validation Deliverables as per SOP Guidelines and in accordance with Good Documentation Practices (GDP)
• Performed configuration of workflows for a project by defining teh activities and also tested teh configured project
• Documented teh Data Migration Plan and Retirement Plan
• Performed teh configuration of TrackWise coordinator for storing teh records
• Used TrackWise integration manager to import and export data
• Performed data migration using TrackWise configuration migrator
• Determined teh migration paths
• Prepared and validated migration snapshots for database backup and restoration and also performed configuration changes with snapshots in place
• Upgraded teh migration paths.
• Used HP Quality Center for bug tracking, reporting and following up with development team
• Updated teh Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution
• Interacted with Subject Matter Experts (SME) to understand and document teh workflow and functionalities on different modules used in TrackWise system.
• Involved in performing teh GAP Analysis, Root Cause Analysis of teh system and develop Remediation Plan
• Responsible for documentation of all aspects of teh Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 regulations.
• As a Member of Change Control Board, made sure all teh changes to an existing system are properly documented and given appropriate change control numbers

Confidential, Ann Arbor, MI

Sr. Validation Consultant

Responsibilities:

• Designed architectural diagrams, process map/workflow and entity relation maps of teh documents or process using MS Visio.
• Responsible for developing Validation Plan.
• Written User Requirements specifications, Functional Requirements specifications document, Design Specification document in compliance with 21 CFR PART 11 Requirements.
• Reviewed and updated end to end validation documentation for IRMS, Track wise (CAPA) to ensure compliance with company policies and procedures.
• Hands on review of teh 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.
• Developed OQ and PQ test cases for Track wise and IRMS
• Drafted IQ test cases for verifying configuration of Track wise workflows.
• Reviewed and tested IBM Cognos reporting functionality for IRMS6.0.
• Communicated and worked with PV group and developed suitable requirements as per URS specifications.
• Developed Performance Qualification for Citrix based tool MIRS - IRMS
• Coordinated teh execution of Operational Qualifications Test Scripts with different modules and specifications.
• Assisted in documentation and development of SOPs for Track wise and IRMS 6.0 application.
• Conducted Regression testing and run teh scripts in validated environment for performance of teh application.
• Wrote IQ, OQ and PQ and developed Data migration protocols and conducted teh dry run in Quality Center.
• Developed Detailed Risk Assessment documentation for managing teh risk levels used before validating teh system.
• Developed Trace Matrix document for mapping teh URS, FS, DS (Design Specification), IQ, OQ and PQ
• Developed test scenarios for testing workflow paths in Track wise.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Performed front end testing, positive and negative testing, GUI testing, and regression testing
• Performed GAP Analysis and prepared Remediation Plans.
• Conducted reporting and tracking of defects using Quality Center.
• Utilized Documentum and created documentation in all phases of teh SDLC
• Created and maintained teh Requirement Traceability Matrix (RTM) for teh application.
• Responsible for storing and maintaining teh documents to comply with 21 CFR Part 11 requirements.

Confidential, Fort Washington, PA

Validation Specialist

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.
• 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:

• 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 training documentation for teh various SOP training.
• Involved in writing audit plans for teh quality department
• Expertise in audits and assessments on documents and systems.

Confidential

Technical Writer/ Validation Analyst

Responsibilities:

• Using backward/forward tracing of requirements and finding source using Requirement Traceability Matrix (RTM) for teh application.
• Wrote documents for reports that can be queried by type of adverse event, disease and principal investigator.
• Created teh strategy document that defines teh SAP test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting teh effort.
• Wrote SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11 and GLP requirements.
• Involved in executing teh test scripts of SD, MM, PP, WM, IM modules of teh SAP implementation.
• Followed good test practices to document teh test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Executed and reviewed teh test scripts for new SAP transactions, Customized transactions, tables.
• Developed Test plan and written several test scripts for validation testing.
• Wrote GAP Analysis report and Remediation Plan document.
• Reviewed and Documented IQ/OQ/PQ protocols.
• Performed Load Testing, Black Box Testing, GUI Testing and Functionality Testing for teh entire application.
• Developed Test Cases and Test Scripts to perform regression testing using Win Runner.