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DescripciónDescription
Provide technical validation and compliance consulting and project leadership on various technology development and implementation projects, including planning, solution design, testing, and support. Developing and managing GMP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports. Conducting System Compliance Risk Assessment. Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews. Configuration specifications generation detailing the specific configuration of the systems / interfaces.
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Requisitos Requirements
Minimum of Bachelors in Computer & Electrical Engineering, Computer Science, Chemical Engineering, Industrial Engineering, Engineering Management, MIS or related IT degrees. Minimum 1 year work experience Pharmaceutical or Medical Devices. Knowledge in: Networking, Microsoft Windows Operating Systems, and troubleshooting computer equipment. Experience in developing validation documentation and testing protocols (IQ/OQ/PQ/UAT). Minimum 1 year in computer systems validation and qualifying various IT systems used in pharma environments / QA within FDA (GMP) regulated environments. PROFESSIONAL SERVICES CONTRACT
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