Computer System Validation Specialist (CSV Specialist)

  • Brisbane Airport
  • Temporary
  • Wed Dec 10 01:23:40 2025
  • 90M0684891

Join our dedicated Quality Assurance team and play a critical role in maintaining our site's compliance with the Code of Good Manufacturing Practice (GMP). As a Quality Coordinator, you will specifically focus on the critical area of Computerised Systems and Data Integrity. You will report directly to the Quality Systems and Technical Support Lead and contribute to the continuous development of a robust Quality System.

Key Responsibilities:
  • Computerised Systems Validation (CSV): Support the QA department by providing effective and compliant advice on computerised systems, data integrity, and validation activities.
  • Compliance: Ensure strict adherence to GxPs (Good Practices), Global Quality (GQ) documentation, local regulatory requirements, and HSE (Health, Safety and Environment) procedures.
  • Quality System Maintenance: Participate in site-wide Quality observations, driving continuous improvement, and assist in maintaining the validated state of GxP Computerised Systems.
  • Documentation & Review: Produce and maintain essential documentation, including Protocols and Reports, pertaining to validation, qualification, and periodic reviews.
  • Technical Support: Provide support and advice to local GxP Computerised System owners, assist with GxP risk classification, and manage the inventory of GxP Computerised Systems.
  • Collaboration: Work closely with cross-functional teams including Quality, Production, Warehouse, Engineering, and Planning.
What You Will Bring:
  • Proven quality mindset and adherence to Global Quality Policy, Standards, and Processes.
  • Experience with GxP regulations, particularly in relation to Computerised Systems and Data Integrity.
  • Ability to produce high-quality technical documentation (Protocols, Reports).
  • Strong communication skills to effectively relay technical and general issues.
  • A proactive approach to continuous improvement and ensuring "Right First Time" across analytical and plant processes.
How to Apply:
If you are a detail-oriented professional with a passion for quality and compliance in a GxP environment, we encourage you to apply. Send your resume today via the apply button.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.