Computer Systems Validation Consultant

The Computer Systems Validation Analyst - Contractor will be responsible for validating computer systems to ensure compliance with relevant regulations such as 21 CFR Part 11, Annex 11, and cGMPs. Essential duties include, but are not limited to the following: * Validation activities for computer system implementation projects (SAS, EDMS & others) * Collaborate across functions with IT, Business, Vendors, and Consultants to plan, coordinate, and execute computer system validation activities * Author requirements for computer systems to ensure compliance with regulations such as 21 CFR Part 11, Annex 11, and cGMPs * Perform and lead risk assessment exercises in support of computer system validation * Author validation documents such as Validation Plans, Test Plans, Deviations, and Summary Reports * Oversee user testing and ensure validation testing is conducted in an appropriate and timely manner * Analyze and summarize validation results * Work collaboratively with Quality Management to support improving computer system validation processes and practices * Assist with training around computer system validation, quality practices and/or applicable regulations as needed. * Participate in the change control process Requirements: * Direct hands-on experience validating GxP Computer Systems * 5 -7 years related experience in cGMP/FDA regulated industry. * Familiarity with GMP and other approaches to System Development Life Cycles (SDLC), GAMP * Generally IT knowledgeable and excellent problem solving skills * Good oral and written communications skill * Able to work independently * Strong knowledge of 21CRF Part 11, Annex 11 and cGMPs Education: * Bachelor's degree in computer science, technical discipline or equivalent

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