The CSI Initiative is a global critical program initiated to assist plants to identify and remediate any compliance GAPs identified during a CSI assessment.
The goal is to improve patient safety and information quality and compliance thus reducing the risk of inspection and audit observations by being compliant with the last FDA, EUDRALEX and other regulatory agencies.
CSI assesses compliance in access security, data integrity, traceability, validation and periodic reviews.
The program also seeks a long-term improvement in understanding and using good Data Integrity practices
These resources are to support the extra effort in that department for involved plants, regarding the validation (drafting, exciting protocols…) and remediation activities as per planned and agreed.
What you’ll do
- Inventorying systems
- Assessing systems in production and labs against data integrity requirements to identify and evaluate the magnitude of GAPs (High, Medium, Low)
- Fixing documentary GAPs (e.g. missing SOP)
- Fixing technical GAPs (e.g. User segregation of duties, folder protection, software upgrade)
- Drafting validation packages (URS, FDS, IQ, OQ, PQ)
- Executing validation testing
- At least 3 to 5 years’ experience in IT validation related roles, of which at least 1 to 2 in automated systems
- English Fluent