Computer Systems Validator

5 hours ago

Australia beBeeSystemValidation Full time $90,000 - $120,000
System Validation Expert

Southern Star Research is a leading Australian company providing clinical research services. We value our staff's contributions and foster a positive work environment.

We are seeking a talented System Validation Specialist to join our team remotely. You will lead on maintaining compliance, complete ongoing CSV for established clinical systems, and conduct initial CSV for new system implementation and significant updates.

Key Responsibilities
  • Maintain corporate computerised system inventory.
  • Track and manage CSV and related tasks for GXP systems.
  • Liaise with System Owners to ensure computerised systems are maintained in a validated state.
  • Develop or review proposed Clinical Trial Computerised system change control for CSV related projects.
  • Collaborate with IT team to monitor computerised system purchases, installation, validation, continued evaluation to decommissioning of these systems.
  • Review vendor supplied CSV documentation for suitability during initial assessments and system updates.
  • Create, review and approve internal CSV documentation.
  • Create, review and approve CSV SOPs and provide guidance and training where required.
  • Ensure annual reviews of user access and periodic reviews are performed for computerised systems.
Requirements
  • Bachelor's degree (preferably in science or IT field) or equivalent experience.
  • Minimum 2 years' experience operating in a GCP or GxP environment with CSV experience.
  • Previous experience in Veeva Vault CTMS and/or eQMS essential.
  • Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time.
  • Good written and verbal communication skills.
  • Able to work harmoniously with other people and work independently.
About Us

This is an ideal opportunity for someone looking to contribute to our expansion into the APAC region and join a passionate team committed to quality, collaboration and continuous improvement.

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