Description
CSV Compliance Officer
Brussels region
12 months
We are looking for someone for the following role:
- Improve computer system compliance within the customer
- Ensures documentation and practices meet quality standards, applicable regulatory compliance and IS guidelines/policies.
- Review user requirements, functional design specification, technical design specifications for clarity, Good documentation practices.
- Review the accuracy and completeness of software validation deliverables created by the project functional process workstreams and the data migration, authorization and Infrastructure cross functional Project workstreams
- Perform Validation and Qualification of GXP/Non GXP systems and infrastructure
- Write and execute Computer System Validation (CSV) Protocols and Validation Summary Reports
- Provide CSV expertise and risk analysis
- Perform CSV GAP Analysis and develop the corresponding Remediation plans
- Coordinate that software systems are implemented in conformance with CSV regulatory requirements and are in line with GAMP 5 standards
- Supply technical guidance on global and local CSV policies and procedures
Profile:
- Experience in Validation Engineering in FDA regulated Pharmaceutical or medical devices environment with concentration in Computer System Validation (CSV)
- Experience with CSV in a SAP environment
- Experience with the design of Validation documents like Validation plan, IQ/OQ/PQ Protocols, Test cases and Traceability Matrix, Summary reports.
- Knowledge of FDA 21 CFR Part 11, 50, 58, 210, 211, 312, 314 and 820 and general principles of Software Validation Life Cycle.
- Familiar with CSV compliant testing applications
- Familiar with Infrastructure Validation is a plus
- GxP advanced knowledge
- GDPR basic Knowledge
If you are interested, please send in your CV to discuss further.