Computer Systems Validation Lead

Full Time
Czech Republic
Posted 1 year ago

To lead the eCompliance activities of GxP projects with ERP and advanced analytics as the key areas. Ensure that the computer system validation strategy is effectively implemented in the GxP systems and that they remain compliant throughout their life-cycle. Support the on-going implementation of data integrity controls within the IT systems landscape. Support the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) as well as IT project related documents in line with quality and regulatory requirements in the respective IT function.

Key Responsibilities:

  • Support the development and drive the implementation of the eCompliance strategy and one CSV process in line with the quality and regulatory requirements within the assigned IT functions to ensure effective and compliant quality oversight over GxP computerized systems.
  • Ensure the eCompliance strategy is fully integrated into the assigned IT function’s strategy.
  • Develop and integrate appropriate risk based models for CSV activities of GxP systems within the assigned IT functions.
  • Liaise effectively with IT, all eCompliance personnel across other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems are in place, maintained and opportunities for continuous improvement identified and implemented.
  • Ensure IT procedures and tools (e.g. ICE Methodology, IGM framework) accurately integrate and align with eCompliance and GxP related requirements.
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