- Primarily Quality support for CIP Skids and associated CIP Loops
- Support the direct impact equipment vendor assessments and support the PQA review and approval of CQV documentation.
- Support the review and approval of construction documentation, perform P&ID walkdowns, risk assessment and construction activities that required PQA assistance.
- Support the review and approval of all CQV generated documentation, including but not limited to; URS, EDR-DQ, SIA, FAT Wraparounds, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
- Align with CQV-on-CQV process to be utilised on Project. With consideration given to ASTM E2500, Grouping, Family Approach and Leverage approach, towards testing for all Systems, from FAT-IOQ.
- Support GMP reviews on behalf of client, at 30%, 60% and 90%, manage and close all actions generated from GMP reviews.
- Support the Turnover package reviews, both Vendor and Contractors. Align with CQV in relation to documentation deliverables for Vendor Data Requirements (VDR) and Table of Content (TOC).
- Minimum 5 years QAV Biotech experience on Large Scale Projects - CIP
- SME on all Quality and Compliance issues - minimum 15 years - CIP
- Working knowledge of ASTM E2500 / Leveraging Verification process
