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Computer Systems Validation Specialist

2 months ago


Melbourne, Victoria, Australia Slade Health Full time
About the Role

The Computer Systems Validation Associate will play a crucial role in implementing the Slade Health computer systems validation program. This includes customer-facing, operational, quality, and facility-focused systems.

Key Responsibilities
  • Assist in developing, implementing, and executing validation protocols and procedures to ensure computer systems meet regulatory agency requirements and internal company standards.
  • Maintain and update operational systems to ensure timely validation.
  • Prepare User Requirements and review design information.
  • Design and prepare validation protocols, TMX, and summary reports.
  • Coordinate and perform computer systems validation projects as per approved protocols.
  • Review executed protocols and route for approvals.
  • Prepare validation and technical reports as required.
Requirements
  • Bachelor's Degree in a science-related discipline or equivalent experience.
  • Experience in developing, executing, monitoring, and managing computer systems validation activities in GMP regulated industry.
  • Experience in the GMP manufacturing industry is desirable.
  • Demonstrated technical, protocol, and report writing skills.
  • Proven time management skills with ability to prioritize workload and meet deadlines.
  • Advanced computer literacy and sound keyboarding skills.
  • Understanding of aseptic compounding processes and flows is highly desirable.
What We Offer

This is a permanent full-time position working 76 hours per fortnight. Hours are typically 9am – 5:30pm, but we are flexible as long as the 76 hours per fortnight is met.

Slade Health is a national provider of aseptically compounded chemotherapy, antibiotics, and analgesic medicines. We operate TGA Licensed manufacturing facilities in various locations.