Regional C&Q Support
The Regional C&Q Support reports to the C&Q Lead and is focused on engaging the packaged equipment/system suppliers and facilitating with project C&Q deliverables for SGOPs ADC Manufacturing Facility, including but not limited to:
- User Requirement Specifications (URS)
- Requirements Traceability and Testing Matrix (RTM)
- Receipt Verification (RV)
- Inspection Test Plan (ITP)
- Design Review (DR) / Design Qualification (DQ)
- Pre-FAT testing
- Factory Acceptance Testing (FAT)
- Stage Gates (A0, A1)
- Vendor Turnover Package (VTOP)
Roles and Responsibilities
- On-site presence: Located primarily at main supplier factory location during design, fabrication, FAT, and pre-shipment phases; required to travel and be embedded with other vendors/suppliers during critical execution and preparation, as applicable.
- Quality by Design (QbD) and C&Q lifecycle alignment and coordination: Close liaison with packaged equipment/system suppliers to align on C&Q test approach and deliverables derived from Validation Master Plan (VMP) and C&Q Execution Plan (CQEP) to agreed scope, schedule, quality, and safety.
- Stakeholder and interface management: Serve as regional representative and focal point between suppliers and AZ stakeholders including C&Q Program Manager, C&Q Lead, Quality Lead, Subject Matter Experts (SMEs) and/or System Owners to align on C&Q requirements.
- Suppliers’ management: Manage deliverables such as Vendor Turnover Packages (VTOPs), Construction Turnover Packages (CTOPs), suppliers’ Inspection Test Plan (ITP), Factory Acceptance Testing (FAT) protocols and Site Acceptance Testing (SAT) protocols, where applicable, as part of C&Q documentation lifecycle delivery.
Ensure completeness and quality of Vendor Turnover Packages (VTOPs) to enable smooth transition into site C&Q (CTOP, SAT, IQ/OQ).
Readiness management - Drive vendor readiness for Design Qualification (DQ), Pre-FAT, and FAT by ensuring documentation, test protocols, and systems are aligned and approved ahead of execution.
Compliance:
- Ensure deliverables comply with regulatory, quality and SHE standards.
- Implement global standards and procedures and maintain audit-ready documentation.
- Define and enforce compliance for the scope area.
- Set metrics and intervene to correct performance as needed, especially related to non-compliance, quality risk, or deviation from approved requirements.
- Key understanding of the design and relevant aspects to C&Q – able to notify and flag where construction is making changes against approved design without client approval / notification.
- Perform technical reviews of supplier design documentation (e.g. P&IDs, specifications, control strategies) to ensure compliance with URS and GMP requirements, as applicable (RTM/DQ).
- Ensuring all documentation generation and data entries follow Good Documentation Practices (GDP).
Controls and reporting:
- Establish integrated controls for risks, changes, issues, and progress.
- Provide transparent reporting against performance baselines and the master plan, escalating and driving recovery actions when required.
- Provide continued oversight QbD of fabrication, documentation, and construction testing activities real progress.
- Provide visibility on constraints, and risks (e.g. fabrication limitations, local practices, workshop constraints) that may impact project delivery.
Schedule accountability:
- Own scope schedules.
- Track commitments, forecasts, and variances.
- Manage schedule performance to deliver within approved parameters.
Requirement
- Willing to travel for a long period around Europe as required.
