CSV lead - Pharmaceuticals - Cork, Ireland - 12-Month Contract+
We are recruiting on behalf of a leading global pharmaceutical client based in the stunning surroundings of Cork, Ireland. Due to a large capital investment and multiple projects on site, the client is looking for a CSV Lead with to join their team.
Responsibilities:
- Develop CSV strategies and documents as listed previously by working closely with Quality Assurance representative once identified
- Review and obtain approval for documents as per policies and procedures
- Work collaboratively with SI to ensure technical deliverables are compliant with CSV expectations, plans, and methods
- Work collaboratively with the vendors of the PE to elaborate appropriate associated CSV packages
- Work collaboratively with other functional groups to ensure alignment, resolve discrepancies
- Take part in Supplier Assessments, Risk Assessments, and Data Integrity Assessments
- Abide by all safety requirements and procedures of their role
Requirements
- 10 years Computer System Validation experience (or equivalent experience)
- 5 years working in Biopharma engineering, operations, or manufacturing
- 5 years’ experience with MSOffice suite
If you are local to Cork and interested in discussing this position, please submit your profile and I will be in contact at my earliest convenience.