2. BACKGROUND
The NRC is building a new permanent, GMP-compliant clinical trial material facility (CTMF) at its Royalmount Avenue site in Montréal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage.
As a member of the multidisciplinary project teams, the consultants specialized in Quality Assurance, actively participates in all stages of the implementation, validation and operationalization of the CTMF in compliance with applicable Health Canada, European and FDA regulations, internal policies and procedures.
3. OBJECTIVE(S)
The consultants will provide quality assurance support during the implementation, validation and operationalization of the CTMF
4. DESCRIPTION AND STATEMENT OF WORK, DELIVERABLES AND TIMELINES
Review and approve documents generated for the following processes:
1. Equipment and facility validation
2. Product tech transfer
3. GMP processes for facility operationalization and start-up such as:
3.1. Access Management
3.2. Alarm Management
3.3. Analytical Method validation
3.4. Batch Record
3.5. Batch release
3.6. Buffer/media prep
3.7. Clean Utilities
3.8. Material Cleaning (manual and part washer)
3.9. DSP (Downstream processes)
3.10. Filtration Validation
3.11. Incoming material release
3.12. Pest control
3.13. Preventive Maintenance / Calibration Program
3.14. QMS (Deviation, change control, CAPA)
3.15. Room classification (gowning/material/EM)
3.16. Room Cleaning & Sanitation
3.17. Sampling
3.18. Sterilization Validation
3.19. Supplier Management
3.20. Training
3.21. USP (upstream processes)
3.22. Warehouse
