CSV Specialist

Employer
Systematix
Location
UK
Salary
Competitive
Closing date
23 Mar 2021

Job Details

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 for Information 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
  • 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.
  • 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.
  • 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 remote contract, based in the UK area.



APPLY NOW

If you are interested in finding out more please contact us or submit your resume to: jobs@systematix.com

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