Science Solutions - CSV Officer - Pharmaceuticals - £30k-£45k
A Pharmaceutical CDMO in the North East are currently recruiting for a CSV Officer on a permanent basis responsible for leading site-wide validation of computer systems in accordance various international standards and guidelines (ICH, GAMP, Orange Guide, Eudralex Vol 4, etc) and act as a subject matter expert for CSV related projects.
As a CSV Officer you will have strong validation knowledge and prior experience with validation of computer systems within a highly regulated environment and be comfortable liaising with various internal and external stakeholders, partners, clients, vendors etc.
Responsibilities
- Lead, manage and maintain all on site computer system validation activity in accordance with various guidelines
- Participate in Data Integrity assessment, quality risk management and remediation planning
- Act as SME for CSV projects
- Ensure Data Integrity considerations are incorporated into all commissioning/decommissioning projects, supporting continual development of Data Integrity in the QMS
Key Requirements
- Strong validation background within the Pharmaceutical, Biotech, Medical Device industries
- Excellent knowledge of GMP including Orange Guide, Eudralex Vol 4 and ICH
- Demonstrable experience of change management
Interviews for this CSV Officer position are imminent so please apply now or contact Gareth Gooley at Science Solutions for more information
