Computerised System Validation Engineer

Recruiter
Reply
Location
London, United Kingdom
Salary
Competitive
Posted
06 Jul 2022
Closes
10 Jul 2022
Ref
15717872
Job Function
Other
Industry Sector
Finance - General
Employment Type
Full Time
Education
Bachelors
Computerised System Validation Engineer

Tasks
  • Coordinating validation planning and compliance across the company's project and operations teams, working closely with project and operations managers
  • Working with internal and customer teams on impact/risk assessment of system changes, deviations and defects as well as preparing risk assessments
  • Critical appraisal of validation evidence and documentation to ensure this meets company and customer standards
  • Communicating with customers and suppliers on validation activities, including guidance and agreement on validation approaches
  • Identifying areas where validation processes or documentation can be optimized, automated or improved; coordinating improvement initiatives
  • Leading or assisting in CAPA investigations, root cause analysis, action setting and documentation, where these relate to validation
Benefits
  • Extensive training opportunities
  • Structured career progression - at Reply we encourage quick career growth and will give you the tools and guidance to achieve subject matter expertise and management capabilities
  • Diverse and vibrant environment - you will be surrounded by peers who share your passion for technology and innovation
  • We offer a competitive salary, bonus and leave package as well as optional involvement in Reply activities
  • Flexible hybrid working
Qualifications
  • Be analytically-minded, with the ability to logically analyze impacts and risks according to GxP principles
  • Have a questioning mindset, with a desire to improve and automate processes
  • Required CSV experience in a highly regulated (GxP, healthcare or similar) commercial software development or IT service and operations organization
  • Be able to demonstrate strong working knowledge of GAMP5 and Annex 11 (or similar standards)
  • Be technically literate with solid knowledge of the software development life cycle, IT service and operations
About Solidsoft Reply
Solidsoft Reply is the Reply Group company specialised in developing digital healthcare solutions for patient safety and closed-loop medicine management. We partner with Healthcare and Industry, helping our customers succeed through our expertise in designing and implementing innovative solutions, and through our continued commitment and investment in Microsoft technologies and the Microsoft Azure cloud platform. We are a published thought leader and deliver software and services via our team of highly skilled and competent people.

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