Computer System Validation Specialist
1 week ago
**Computer System Validation Specialist**
**_FULLY REMOTE Role Model _**
**Cadent Sourcing is partnering with a** **rapidly growing AI technology company, based in Dublin. They **provide software solutions for both non-clinical and clinical Pathology.**
We are seeking a **Computer System Validation **Specialist **to join the team within the Preclinical department.
This is a vital role in the Company’s Big Data team; you will be given autonomy and freedom in your role.
**Requirements**:
- Bachelor’s degree (or higher) in a relevant discipline.
- 5+ years’ experience in a similar role delivering validated IT solutions, ideally in the Biotech or Pharmaceutical industry or other regulated environments.
- Minimum of 2 years of experience working in a **GxP **environment.
- Expert knowledge of **GAMP5.**:
- Experience in the following is essential **GxP computer validation**:
- Experience with **AGILE** and **SCRUM.**
**The Role**
- Collaborate with clients on projects to validate the Patholytix Preclinical SaaS for regulated intended use.
- Develop and maintain Validation and Test Plans, aligned with the overall project plan for a customer environment.
- Manage customer facing deliverables of our Software Development LifeCycle (SDLC).
- Ensure Change Control Summary Reports are delivered to clients in a timely manner post-software release.
- Work as part of a cross-functional team to identify and implement procedural controls to mitigate issues found during testing.
- Identification and resolution of any issues (process or software) that may cause Regulatory scrutiny for our validated clients.
- Work closely with validated clients to navigate their Change Control processes when upgrading between versions of the Patholytix Preclinical platform.
**Job Types**: Full-time, Permanent
**Salary**: £60,000.00-£75,000.00 per year
**Benefits**:
- Flexitime
- Work from home
Schedule:
- Monday to Friday
Reference ID: EV
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