Summary

Validation Skills FDA QSR, 21 CFR Part 820.30, 21 CFR Part 11, EU Annex 11, IEC 62304 Software Life Cycle Processes, ISO 9001, ISO 13485 Quality Standard, ANSI/AAMI/ISO 14971, CAPA, FMEA, DOORs, Agile PML, QAAD Quality Management, LiveLink, SDLC, Trackwise, Oracle 10, ValGenesis, GAMP5, LIMS, CSV, COTS, cGMP, cGLP, cGCP, cGDP, HIPAA, Change Control and Configuration Management of cGMP systems. Deliverables Master Validation Plans, Risk Analysis 21 CFR Part 11 Assessments, User/Functional Requirements, IQ/OQ/PQ Protocols, IQ/OQ/PQ Summary Report, SOP, Design Specs, Test Case Authoring, Execution of Test Cases, UAT Test Cases, RTM, Requirements Traceability Analysis, Regression Impact Analysis, Document Management, Gap Analysis, CAPA, FMEA, Root Cause Analysis, Change Controls, ERES Assessment, Documentation Traceability.

Work Experience

Confidential

• Analyze product requirements for Individual and Hospital use data management software application.
• Work with Business Analysts and System Developers to deliver quality product to the customers.
• Identify the high-risk points and the priorities of the application.
• Develop Traceability Matrix and appropriate test cases and test protocols.
• Maintain documentation in accordance with GxP guidelines.
• Perform the protocols execution.

Confidential

• Lead Verification and Validation activities on multiple Change Requests CRs and Projects PRs for different pharmaceutical and clinical COTS Out Of the Shelf computer systems, including WinKQCL for Endotoxin readers, Oracle MES system, Bracket Web Response System IWRS , Oracle and Registrat EDS systems, SQL Servers Virtualization, OBIEE System, Livelink, LIMS.
• Use Trackwise Quality Management System for monitoring CR executions, corrective actions and projects completion.
• Complete and verify associated documentations in accordance with GxP and company SOP requirements.
• Execute UAT, OQ, PQ. Provide Page-By Page reviews for executed IOPQ scripts. Generate Validation discrepancy reports VDRs and correction actions CAPA . Ensure development and execution of Computer System Validation documentation, including Validation Master Plan, Design Specifications SDD , URS, Test Protocols, Risk Analysis, Traceability Matrix, Summary Reports, SOPs and other related documents. Provide Computer System Validation expertise to assigned projects. Responsibilities include but are not limited to managing validation projects, developing system life cycle documentation, and providing consultation on CSV projects. Support quality process for multiple projects involving software systems. Review and assist with development of documentation for FDA regulated products. Maintain GMP documents and standard files, review executed scripts, prepare Final FR and Validation Summary VSR reports.
• Work with Software R D, Systems Engineering, IT, Quality Assurance, and Operations to develop validation testing strategy to reduce costs and streamline execution, resulting in achievement of project milestones and high level of quality.

Confidential

• Analyze product requirements and develop appropriate test scenarios for software that runs on multiplatform OS Windows, Mac, Linux
• Deliver verification and validation procedures for new and changed features
• Provide high quality, on-time testing of product releases in SCRUM environment
• Work with project managers, developers, and end users to ensure quality and usability of the product
• Report weekly project status updates to management with focus on milestone accomplishments, challenges and status of project schedules

Confidential

• Provide expertise in the development, coordination, and execution of computer systems validation, COTS and custom software in accordance with GxP regulations and harmonized global company procedures.
• Utilize Trackwise Quality Management System for monitoring CR executions, corrective actions and projects completion.
• Author and implement Validation Plans, User/Functional/Design Requirements, IQ/OQ Test Scripts, User Acceptance Test Plan UATP / PQ, Traceability Matrix, Summary Reports, System SOPs and other related documentation.
• Perform verification, simulation, end-to-end testing, debugging, and defect isolation of new software that provide control, communications, and power distribution for virtually any remotely operated system with multi-carrier real device with Oracle10 resided database.
• Verify final integration of the company products with the widest selections of embedded operating systems OS and execution environments
• Lead Software QA activities for creating test specification, testing, validation and remain controlled for an official master copy of software executable for creating copies for production release
• Identify and resolve quality/compliance issues in documentation resulting in reduction and closure of validation discrepancies. Perform FMEA, CAPA and root cause analysis for deviations associated with validation projects to achieve long term solutions.

Confidential

• Conduct software verification and validation activities for Thermage's ThermaCool NXT medical device in compliance with FDA Quality System Regulation.
• Work with other team members to evaluate risk for certain application areas to determine testing coverage and plan.
• Maintain documentation in ISO 9001:2000 regulated environment.
• Assist with documents preparation for FDA audits.
• Work closely with other groups such as regulatory, document controls, manufacturing operations, customer service and engineering to ensure compliance and efficiency.