Validation Analyst
IntelliLink Technologies
Job Description Prepare, maintain validation and compliance documentation, validation strategies, testing approach for the successful validation of Laboratory and Manufacturing systems including development of validation master plans (VMP), process flow diagrams, test cases, and standard operating procedures. Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GxP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Travel to various unanticipated locations in the United States to interact with clients for short or long term assignments.Salary: $111,717/yearWork Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)Requirements:MS or foreign equivalent in Pharmacy, Chemistry or related + 1 yr of experience as Validation Analyst, QA Engineer or related, and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE). BS or foreign equivalent in Pharmacy, Chemistry or related + 5 yrs of experience as Validation Analyst, QA Engineer or related, and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE)Job Location: 101 College Road East, Suite 303, Princeton, NJ 08540Contact: Subha Katha, HR Manager IntelliLink Technologies, Inc. View email address on click.appcast.io 101 College Road East, Suite 303 Princeton, NJ 08540 Job Tags Validation Analyst, FDA, GAP, GxP
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