Project Director, Senior Quality Engineering, Software Project Manager, Software QA Manager, MS Dynamics AX Developer
Health, Medical Technology, Cardiovascular Technology, Business Consulting, Music
This candidate has a hands-on technical project manager with over 20 years of industry experience in software development, computer systems validation, process validation, and quality assurance with some of the largest healthcare companies in the world, including a small biomedical start-up. They also have over 7 years of experience implementing MS Dynamics AX ERP.
In a recent role, this candidate Managed and validated the MS Dynamics AX ERP for manufacturing allergen-specific Ig E assays. Also managed and validated EtQ Reliance enterprise quality and regulatory management systems (EQRMS).
This candidate took over a validation project management role from an MS Dynamics AX ERP integration vendor in a previous role. This individual managed the cGMP compliance verification and validation of the software for manufacturing of allergen-specific IgE assays, state-of-the-art allergy testing technology that provides 20 specific IgE results from a single serum sample. This candidate performed impact analysis due to infrastructure changes from legacy systems. The individual facilitated the business process mapping based on Microsoft Dynamics AX-supported services. The candidate managed the verification and validation activities by applying risk-based assessment to the entire software implementation and deployment lifecycle (SDLC). The validation deliverables included; a validation master plan, preliminary hazard analysis, system hazard analysis, User Requirements Specification, Requirements Specification, traceability matrix, IQ, OQ, and PQ protocols.
On a project, this candidate managed the overall development and validation of the SCADA/MES computer systems, including the integration with the corporate ERP system. They wrote the systems development plan, validation master plan (VMP), User Requirements Specification (URS), and Software Requirements Specification (SRS) for the computer systems. Managed and reviewed the verification and validation protocols (IQ, OQ, and PQ) for the MES and FAT/SAT/IQ/OQ/PQ for the new manufacturing systems. Executed the project-wide ERP gap analysis and identified the needs for implementing the manufacturing information systems before the new product launch, including Supervisory Control and Data Acquisition system (SCADA), Manufacturing Execution systems (MES), and Product Label Management Systems (Bartender) in a clean room environment. Managed the MES/ERP interface connectivity testing and ERP/PLC/physical device (label printers, scanner, etc.) connectivity testing. Developed the entire design control plan for new product development by identifying FDA Design Control compliance tasks for a family of disposable medical products for both clinical and consumer markets. Developed the entire suite of the Software Development Life Cycle (SDLC) documents and implemented them in SOPs.
This candidate has skills in:
- Compliance and Validation: Validation of GMP sensitive modules, FDA Quality System Regulation, IQ/OQ/PQ, FDA Compliance, cGMP/cGLP/cGCP Audits, 21 CFR Part 11, LIMS, MES, ERP, SCM, BMS, Metrology.
- Application Platform: Client-Server, PC (Win 7, Vista, XP, NT, WIN2000), Windows Server 2008 R2, Unix, Linux OS (Debian, Ubuntu, etc), Sun Solaris, HP-UX, AS/400, Apache Web Server, MS Hyper-V R2, VirtualBox, VMware.
- Software: Python, Java, JavaScript, Perl, C, C++, X++, HTML, XML, XSLT, X-Path, MS IIs Web, DB2, Informix, Oracle, Oracle PL/SQL, Oracle SQL Developer, MySQL RDBMS, MS SQL Server 2008, .Net, Visual Studio 2010.
- Firmware/Embedded Systems Prototyping: NXP ARM Cortex-M3 microcontroller LPC1768, LPCXpresso1769, FreeRTOS, Keil MDK-ARM Toolchain, C/C++
- Software QA: Selenium IDE, Selenium RC, Selenium Web Driver, VMWare, ApTest, HP Quality Center, Mercury XRunner, Mercury WinRunner.
The candidate also has Certification/Affiliation in:
- Certified Software Quality Assurance Engineer (CSQE) Certification
- Certified PGP Universal Server Engineer
- Member of Project Management Institute (PMI)
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