Description
Our client is a pharmaceutical company and is currently looking for a CSV Consultant to help them on a building construction project. The Computer Systems Validation Consultant will work at our client for at least 3 months.
The CSV Consultant will:
- Apply the client validation methodology for automated equipments qualification in the project respecting cGMP and all other applicable regulations (21 cfr part 11, Eudralex)
- CSV tasks including Validation Master Plan, Design Qualification, Installation & Operational Qualification, Performance
Qualification and Validation Reports - Ensure application of SOPs regarding Change Control, Incidents Management, Access Management, Backup and Restore
- Manage, schedule, coordinate and track each qualification or validation activities to ensure timely completion of the validation plan
The Computer Systems Validation Consultant is/has:
- Bilingual French/English
- Knowledge of main automation and IT principles and components (PLC, SCADA/DCS, HMI,
network,) - Knowledge of process control part of standard automated systems
- Knowledge of good practices in electronic records management
- Knowledge of risk analysis methods applicable to computerized systems (such as FMEA)
- Good knowledge of projects and qualification steps, including commissioning
- Good planning skills
Keywords:
CSV, GAMP, computerized systems validation, 21 cfr, CSV