Computer Systems Validation Specialist
4 weeks ago
The Computer Systems Validation Associate will play a key role in implementing the Slade Health computer systems validation program, working closely with the Computer Systems Validation and Reporting Specialist to ensure compliance with regulatory agency requirements and internal company standards.
Key Responsibilities- Develop, implement, and execute validation protocols and procedures to ensure computer systems meet regulatory agency validation requirements and internal company standards.
- Maintain and update operational systems to ensure timely completion of computer systems validations.
- Prepare User Requirements and review design information to ensure compliance with regulatory agency requirements.
- Design and prepare validation protocols, TMX, and summary reports to ensure compliance with regulatory agency requirements.
- 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 (e.g. pharmacy, IT, science, engineering) or equivalent experience.
- Experience in developing, executing, monitoring, and managing computer systems validation activities in GMP regulated industry (ideally following GAMP 5 Guidelines).
- Experience in the GMP manufacturing industry is desirable.
- Demonstrated technical, protocol, and report writing skills.
- Proven time management skills, with demonstrated ability to prioritize workload to meet deadlines and forward plan to ensure work and information is complete and commitments are fulfilled.
- Advanced computer literacy (particularly Word, Excel, Outlook) combined with sound keyboarding skills.
- Understanding of aseptic compounding processes and flows is highly desirable.
This role is offered on a permanent full-time basis 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. It operates TGA Licensed manufacturing facilities in Victoria, Queensland, New South Wales, South Australia, and New Zealand.
Icon Group celebrates diversity and is committed to creating an inclusive workplace for all employees. We encourage applications from all diverse backgrounds.
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