· Ensure compliance with internal and external GxP system policies and regulations.
· Implement or schedule validation testing and studying clinical product characteristics or requirements and conferring with management to determine validation objectives and standards.
· Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation.
· Perform risk assessments in determining GxP applicability associated risk and resulting validation activities per risk.
· Conduct Periodic Reviews per applicable policies and procedures to ensure that the computer systems maintain their validated status.
· Track validation projects and provide updates on the progress to Management.
· Gather User Requirements and author validation deliverables.
· Facilitate risk management and maintain the required controls to ensure system security.
· Support management of Validation Templates.
· Support management of Validation Procedures in terms of authoring/ updating SOPs. Prepare and maintain training material and ensure the personnel involved in projects are adequately trained.
· Support Validation Lead on all aspects of the computer system/ computerized equipment lifecycle during projects and operational phase, including but not limited to the development, review, and execution of validation documentation.
· Ensure proper documentation, testing, communication and stakeholder management for system changes.
This position requires a minimum of Bachelors Degree equivalent or higher in Life sciences, Pharmacy or a closely related field.