Develop and execute GxP computer validation strategy and protocol for processes, software, or equipment within the facility.
Experienced in GAMP 5, 21 CFR Part 11.
Write CFR 21 Part 11 related documentation such as assessments, plans, URS, and FRS.
Write reports summarizing results and statistics for all equipment, or process CSV projects.
Review existing CSV reports and identifies gaps for GMP, and regulatory compliance.
Corrects program errors, prepares operating instructions, compiles documentation of program development, and analyzes system capabilities to resolve questions of program intent, output requirements, input data acquisition, programming techniques, and controls.
Develop strategies and plans to close the gaps in an efficient and technical manner.
|Requisitos - Requirements
Bachelor degree in Engineering and 5-7 years of related experience in an FDA regulated environment.
Experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
Expertise in 21 CFR Part 11 requirements and FDA cGMP.
Knowledge and working application of Validation Principles and guidelines and industry practice.
Knowledge and working application of FMEA and Risk Analysis.
Practical experience in product design and development.
Knowledge and working application of reading and understanding blue prints and technical drawings.
Knowledge and working application of standard operating procedures.
Demonstrated ability to accomplish goals while working across departments is required.
Ability to multi-task and methodically manage projects.