01 ago
|
Experteer Italy
|
Italia
01 ago
Experteer Italy
Italia
Experteer Overview As a Junior CSV Specialist, you will help ensure computer systems used in life sciences stay validated and compliant. You will work with cross‑functional teams to apply GxP concepts and manage validation documents throughout the system lifecycle. This role offers international development opportunities and a clear path to grow within CSV and regulatory domains. You will gain hands‑on exposure to audits and real‑world validation challenges, contributing to high‑impact healthcare projects.Retribuzione / Benefits
- Develop validation strategies and manage lifecycle documentation (planning, requirements, design, testing protocols, release and maintenance) in line with GAMP5 and SOPs
- Ensure regulatory compliance (cGMP, GCP, Data Integrity) across validated systems and maintain lifecycle documentation
- Enforce CSV methodology within project teams and support GxP System Risk Assessment with stakeholders
- Oversee system change requests and related documentation
- Collaborate with technical teams to investigate validation incidents and implement solutions
- Review proposed changes for validation implications to maintain validation status
- Support Senior CSV Specialist during client audits and regulatory inspections
Responsabilità
- Recent graduate with little or no experience in CSV
- Fluent English
- Strong interest in Life Science and Pharma
- Knowledge of computer information requirements legislation (privacy)
Requisiti fondamentali
- international opportunities for development
- flexible work policies
- competitive compensation package
- salary package
- corporate premio
- meal vouchers','Career development','Corporate training
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📌 Junior Csv Specialist Position (Italia)
🏢 Experteer Italy
📍 Italia