Job Description
**About the Opportunity**
Our client is a globally recognised leader in the biotechnology and pharmaceutical industry, at the forefront of innovative medicine. Their Shanghai site plays a critical role in global manufacturing and quality operations.
This is a high-visibility, high-impact senior individual contributor role, serving as the primary Subject Matter Expert (SME) for SAP ERP Computerised System Validation (CSV). You will ensure the ERP application landscape remains in a validated state under global regulatory frameworks, acting as the critical bridge between IT, Quality Assurance (QA), and business stakeholders.
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**The Role**
As Senior SAP ERP Validation Manager, you will serve as the CSV project lead, conducting validation of the SAP ERP system in accordance with the company's Quality Management System (QMS) and applicable regulatory requirements including:
- FDA 21 CFR Part 11
- EU GMP Annex 11
- China GxP regula...