Environment: Our client is currently in need of a CSV Specialist to support Software Validation activities within an ongoing remediation.
Responsibilities: The client is currently in the midst of an on-going remediation project stemming from an FDA Warning Letter. The client is in need of a CSV Specialist for non-product Software Validation. This individual will be from a Medical Device, Pharmaceutical or Biotech background and will be writing/reviewing and approving Software Validation & Software Verification documentation for Manufacturing Software, ERP Systems, Quality System Software/Document Management Systems, and various other non-product software packages.
The consultant will need to understand FDA Regulatory requirements associated with Software V&V and GMP. It would be a plus if this candidate has experience working in a remediation environment as well.
- Medical Device/Pharmaceutical: 3-5+ years
- Software Validation: 3-5+ years
- Writing & Executing Validation
- Remediation Experience