Title: CSV Engineer
Location: Cork, Ireland
- Leading Medical Device company based in Cork are looking to hire Contracting CSV Specialists.
- You will be joining the Pharmaceutical Quality System global team dedicated to the remediation of identified IT infrastructure gaps
- Ensure Regulatory compliance in area of responsibility (Annex 11/15, 21 CFR Part 11, GAMP 5) for GMP pharmaceutical regulatory agencies
- Facilitate and coordinate resources for the identification, creation, review and approval of IT infrastructure documentation.
Work in conjunction with Global IT Infrastructure teams and site teams to identify, create, review, and approve documentation
- Collaborate with iQMS and site teams to review and approve documentation.
- LEAN and Six Sigma philosophy are embedded in your day to day working.
- Experience in the pharmaceutical industry.
- Experience working with validation and qualification projects within GMP regulated environments.
- Solid understanding and hands-on working knowledge of Computer Systems Validation requirements for all aspects of computer systems and infrastructure involved in medicinal product production.
For further information on this CSV role in Cork please contact Karl Lippett on firstname.lastname@example.org or 086-1070950
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