Validation Analyst - DI Automation and Production Systems
Posted on Oct 2, 2019 by Sentinel IT LLP
Validation Analyst - DI Automation and Production Systems Specialist - French and English Speaking
Leading global pharma client require a Validation Analyst as part of a global CSI Initiative. This 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.
Assessing systems in production and labs against data integrity requirements to identify and evaluate the magnitude of GAPs (High, Medium, Low)
Fixing documentary GAPs (eg missing SOP)
Fixing technical GAPs (eg User segregation of duties, folder protection, software upgrade)
Drafting validation packages (URS, FDS, IQ, OQ, PQ)
Executing validation testing
- At least 7 to 10 years' experience in IT validation related roles
- English and French fluent. Other languages are welcome.
- Thorough understanding of Project Management
- Willingness to Travel : 20 to 50%
Please apply now for more details!