Key responsibilities will include:
- Assisting in the preparation of documentation associated with validation plans, user requirement specifications, IQ test protocols, functional test protocols, user acceptance test protocols, and validations summary reports.
- Supporting phases of system testing.
- Maintaining the validated status of business systems.
- Maintenance of Project Traceability Matrices.
- Assisting in the maintenance of the CSV Validation Master Plan.
- Assisting in the maintenance of the Diomed Systems Register.
- Review of vendor supplied CSV documentation.
To be successful in this role, you will need to demonstrate:
- An understanding of validation and the principles of GxP.
- Some previous experience in use and validation experience, of commonly used systems in pharmaceutical environments i.e. LIMS, Chromatography Data Systems, Laboratory Analytical Systems, Manufacturing Systems, eDMS, ERP PVG and Regulatory Systems etc.
- Proficiency in the use of common office applications (Word, Excel etc).
- Good organisational skills and the ability to prioritise own workload around a range of deadlines from different sources.
- Good interpersonal and 'people skills'.
- High attention to detail.
