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Computer Systems Validation Specialist
2 months ago
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.
- 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.
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.