
Computerized Systems Specialist
2 weeks ago
We are seeking a highly skilled professional to support the development, implementation and maintenance of computerised systems.
The successful candidate will participate in the quality assurance program, ensuring compliance with Good Clinical Practices (GCP) and other regulations.
Key Responsibilities:- Maintain a database of CSV tasks and ensure accuracy and completeness.
- Liaise with System Owners to maintain computerised systems in a validated status.
- Review and approve proposed and executed changes in MasterControl for CSV related projects.
- Engage in responsible monitoring of computerised system purchases, installation, validation, continued evaluation to decommissioning.
- Review vendor supplied CSV documentation and create internal CSV documentation.
- Create, review and approve CSV SOPs and provide guidance and training.
- Ensure annual reviews of user access and periodic reviews of computerised systems.
- Communicate effectively with the CSV team, System Owners and the DQA.
- Actively contribute to the Avance CSV Committee as a member and minute taker during routine CSV Committee meetings.
- Bachelor's degree or equivalent experience.
- Minimum 2 years' experience operating in a GCP or GxP environment with CSV experience.
- Formal audit training or evidence based internal / study audit training.
- Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time.
- Excellent written and verbal communication skills.
- A proactive and enthusiastic individual who is a team player.
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