Key Responsibilities
- System administration, maintenance, and patch management
- Testing and validation activities (CSV/GxP)
- System implementation and release support
- Change control and compliance activities
- Audit readiness and documentation
- Root cause analysis and issue resolution
- Collaborate with Engineering, Manufacturing, Quality, and external vendors
Required Experience
- GxP System Validation/Computer System Validation (CSV)
- Change Control & Patch Management
- Compliance & Audit Readiness
- System Lifecycle Management
- CAPA & Risk Management
- Vendor & Stakeholder Management
- Project Delivery & Coordination
Desirable
- GMP, GxP, FDA 21 CFR Part 11, Annex 11
Working Pattern: 2-3 days per week