CSV Officer - Pharmaceuticals

Location Morpeth
Discipline: Pharmaceutical
Job type: Permanent
Salary: ££30000 - £45000 per annum
Contact name: Gareth Gooley

Contact email: Gareth.Gooley@sciencesr.com
Job ref: GG4296_1659713620
Published: 6 days ago

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