our client in Weston, MA is looking for a Validation Analyst with Pharma experience. This is a long term consulting position. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to email@example.com job #: 13-00908 job title: Validation Analyst Position Responsibilities: The Senior Validation Analyst will be a Subject matter expert in validation and quality assurance of corporate systems working on the California Serialization project. The position requires extensive experience with the validation of computer systems for compliance with GMP regulations and FDA regulated 21 CFR Part 11. The person will be responsible for Validation Strategy development, Execution and Testing. The position will be responsible for the development and creation of validation documents including the Validation Master Plan, IQ, OQ, PQ protocols, System Acceptance Documents and Traceability Matrix Documents. Education: BS/BA required • Validation Strategy development experience • Supply Chain experience • Demonstrated strong Analysis skills • Working knowledge of software development and support methodologies • Experience working with change controls and GxP validation protocols • Strong written and oral communication skills • Ability to work in a team-oriented, collaborative environment • Ability to facilitate meetings and follow up with resulting action items • Knowledge of Serialization preferred
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