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Systematix Technology Consultants Inc.
,
Amersham, Buckinghamshire
Computer Systems Validation Specialist
Overview
Systematix is currently looking for a Computer Systems Validation Specialist to further an ongoing IT transition for one of the world’s leaders in Life Sciences technologies. ABOUT THE PROJECT Our client is one of the world’s leading Life Sciences companies, with offices around the globe. As a key member of the transition team, you will be responsible for all validation requirements throughout the transition. You will establish best practices and maintain a global, corporate wide information systems compliance program to ensure that information assets are managed with GxP compliance. Your responsibilities in the role will be: Determining business and system requirements, project planning for validation work-stream, and collaborating with project team members in the development and delivery of validation deliverables. Prioritizing, executing, maintaining, and coordination of CSV activities, evaluation of software applications against design specifications and user requirements Reviewing and assisting in developing validation strategies and associated documentation Development and execution of qualification & validation of documentation and activities forInformation Systems software. This includes qualification/validation plans, test strategies, application migration records, and summary reports Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state). ABOUT THE QUALIFICATIONS Bachelor’s Degree Experience with the validation of Information Systems Technology projects Experience may include but is not limited to the following: Windchill, TrackWise, Master Control, Agile PLM Software, Aegis, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testing, etc. Prior experience in working with Quality Systems is preferred. Strong experience in leading and performing validation activities. Ability to manage internal and external resources to deliver required validation package and execution. Experience working in the GxP landscape A working knowledge of current information technologies. A track record of working in collaboration with cross-functional teams to manage compliance. Excellent written and verbal communication skills, interpersonal and collaborative skills, and the ability to communicate concepts to technical and nontechnical audiences. Exhibit excellent analytic skills, the ability to manage multiple projects under strict timelines, as well as the ability to work well in a demanding, dynamic environment and meet overall objectives. High degree of initiative, dependability and ability to work with little supervision. ABOUT THE ROLE This is a 6-month contract, with the strong intent to extend, located in the Amersham, UK area. ABOUT SYSTEMATIX Systematix is one of North America's largest privately owned National Consulting and Resourcing firms. We provide the highest caliber consulting solutions to a diverse client base that includes all levels of Government and all Private Industry sectors.