System Validation Specialist
In the position of system validation specialist, your responsibilities would be to:
- Perform testing and validation of IWRS and EDC systems prior to their release for client user acceptance testing, with emphasis on user interface, ease of use, and error reduction.
- Perform testing and validation of IDDI internal systems following new development.
- Write user manuals for IDDI systems
- A University degree in computer science or life sciences
- Experience in computer system validation preferably in the clinical trial setting
- Knowledge of 21 CFR Part 11 or GAMP 5 preferred but not mandatory.
- Good attention to details.
- Works well under pressure.
- Excellent communication, organizational, planning and interpersonal skills.
- Must be able to operate independently with minimal supervision