SUMMARY:

• 7+ Years of experience in Testing, Business Analysis, Validation, Technical Writing and Quality Assurance in Pharmaceutical/Medical Device Industry.
• In depth knowledge of FDA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events).
• 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).
• Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Front end Testing and also automated testing tools like HP Quality Center.
• Experience with BI tools, Micro Strategy, Tableau, Cognos.
• Proficiency using Tableau Server, Tableau Desktop, Tableau cloud
• Experience in working with Microsoft Office suite (word, excel, Access, Visio), Power Point and Outlook) for documentation, analysis and presentation.
• Experience in development of Process Flow Diagram, Use Case Diagram, Activity Diagram, and Sequence Diagram by using UML methodology
• Experience in writing and reviewing Computer System Validation Plan/Remediation.
• Experience in writing Risk Analysis, Gap Analysis, and CAPA documents
• Good understanding and practical knowledge on GAMP5 regulations
• Experience in Validation Procedures, technical writing for systems in compliance with cGMP, GAMP, cGLP, and cGCPs.
• Experience in conducting GAP analysis, SWOT analysis, User Acceptance Testing (UAT), Impact analysis, Risk analysis and mitigation plan, dept in writing SQL queries for data extraction, manipulation, analysis, and validation, generating user reports and proficient knowledge of Relational Database Management Systems (RDBMS), and Data Warehousing.
• Strong working knowledge of Windows Servers and Operating Systems
• Excellent knowledge on working principles of COTS Instrumentation
• Strong analytical, debugging, troubleshooting skills and quick learning abilities
• Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs) and Requirement Traceability Matrix (RTM)
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.

TECHNICAL SKILLS:

Microsoft Tools: MS Visio, MS word, MS Excel, MS Power point, MS Access, MS Project.

Databases: Oracle, MS SQL, Sybase Central

LIMS: SQL *LIMS, Labware LIMS

Testing Tools: QTP, Load Runner, Quality Center, and Test Director

Laboratory Equipment: HPLC, Spectrophotometer, Autoclave, GC, UV: VIS &FTIR Spectrometers, incubators and pH meters

Platforms: Windows OS, Mac OSX

Computer System Validation/ Testing: 21 CFR Part 11, 50, 58, 56, 211, 210, 820; Validation Protocols (IQ, OQ& PQ), SOP, cGxPs, Audit Trials, RTM, Remediation Plans, GAP Analysis.

WORK EXPERIENCE:

Confidential, Somerset, NJ

Sr. Technical Writer

Responsibilities:

• Tested New Features and their impact on existing functionality before each release. (Agile Methodology)
• Lead JAD sessions and developing documentation for Technical Requirements and Functional Specifications for all automated workflow using Visio to ensure reusability and validation with the new technological platforms.
• Involved in developing Test Plans, Fish Bone Diagrams and Summary reports for the QMS system implementation.
• Reviewed test cases based on the test plan and in accordance with Good Documentation Practices (GDP)
• Assisted in documentation and development of SOPs for QMS
• Participated Stress and Load Testing using Load Runner.
• Checked the data flow through the frontend to backend and used SQL Queries to extract the data from the database.
• Utilized Documentum and created documentation in all phases of the SDLC
• Created and maintained the Requirement Traceability Matrix (RTM) for the application.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Conducted Risk Analysis meetings to analyze the risk involved in implementing the QMS system in the existing business process.
• Given the new thoughts of the rebranding the existing projects with a new look and feel of the reports in by using MicroStrategy Visual insight.
• Loaded the data warehouse tables with the OLTP files for reporting on MicroStrategy.
• Created Business Process and Activity Diagrams using Visio.
• Obtained detailed understanding of data sources, flat files, various schemas and models.
• Extensively worked with Facts and Dimension tables - architecture to produce source to target mappings based upon business specs.
• Responsible for Validating the control of report laboratory information
• Authored User Requirements and Functional Requirements for QMS that include Reporting requirements
• Expertized in detail workflow of QMS Data Acquiring functionalities
• Developed test scenarios for testing workflow paths in QMS.
• Performed the configuration of QMS coordinator for storing the records
• Performed data migration and determined the migration paths
• Prepared migration snapshots for database backup and restoration and also performed configuration changes with snapshots in place
• Worked on workflows, configuration forms, user and person creating process groups default value classes, dependent classes
• Authored Design Specification document in compliance with 21 CFR PART 11 Requirements.
• Responsible for writing and executing Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to check installation and successful operation of the application.
• 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.

Confidential, Franklin Lakes, NJ

Technical Writer

Responsibilities:

• Prepared and tracked defect reports using defect tracking tool JIRA.
• Gathered requirements by conducting meetings and brainstorming sessions with end users and SME and document them using Requisite Pro - the documentation tool offered by Rational.
• Facilitated JAD sessions involving the management, development and user teams for clarifying requirements and facilitating better communication.
• Authored User manuals for GXP applications
• Data processing functionality form other instruments was validated.
• Drafted Use cases with all SDMS workflows and authored Fish Bone Diagrams
• Expertise in Oracle table data manipulation using SQL queries
• Participated in Weekly meetings and walk through to discuss Defect Priorities.
• Perform Gap Analysis of the processes to identify and validate requirements.
• Extensively involved in data modeling, Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle data base.
• Review the Test Plan developed by the testing team for testing the application.
• Assist the QA personnel in the creation of Test Cases using Rational Test Manager.
• Reviewed and modified existing Standard Operating Systems (SOPs), System Administration, Change Control Procedures and Testing SOPs.
• Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using Test Director and paper based manual testing.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).
• Used Trackwise to generate the change control number and manage the change control flow
• Responsible for authoring and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional Requirement Specification, System Design Specification document.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• 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.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Authored and reviewed Requirement Traceability Matrix (RTM).

Confidential, Plainsboro, NJ

Technical Writer

Responsibilities:

• Gathered User Requirements for all Functionalities like Assets Management, CM, PM and other Maximo Workflows
• Responsible for writing the Validation Plan
• Made sure that the team adheres to the guidelines mentioned in the SOP and training manuals.
• Coordinated the team members and held daily meetings for effective communication of status of the project
• Extensively involved in data modeling, Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle data base.
• Performed Risk Assessment for different tools following GAMP5 procedures
• Prepared and tracked defect reports using defect tracking tool JIRA, POSTMAN
• Involved in creating System operational and Administration SOP’s.
• Reviewed the CAPA, QA Audit, Change Control workflows
• Updated the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution
• Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules.
• As a Member of Change Control Board, made sure all the changes to an existing system are properly documented and given appropriate change control numbers
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Responsible for writing the Validation Report that also includes Traceability Matrix, Anomalies and Remediation Plan
• Reviewed all the Validation Deliverables as per SOP Guidelines and in accordance with Good Documentation Practices (GDP)
• Responsible for performing User Acceptance Testing (UAT) for the application and documented the results in HPQC (Quality Center)
• Developed User manuals and Training manuals, Fish Bone Diagrams
• Performed configuration of workflows for a project by defining the activities and also tested the configured project

Confidential

Tester/ Technical Writer

Responsibilities:

• 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.
• Involved in gathering the User Requirements from the System Owners document for all the software components.
• 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 the work flow of documents
• Actively involved with the application developers in developing the high level System Design Specifications (SDS) documents using JAD Sessions
• 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 with the development team to verify bug fixing and update bug report status using HP Quality Center.
• Expertise in audits and assessments on documents and systems.