The eCSV Compliance Advisor plays a key role in upholding regulatory compliance for computerized systems within a GxP-regulated medical device setting. This position ensures that systems used in product development, manufacturing, and distribution remain in a validated state from inception through retirement.
Key Responsibilities
- Assess new software and systems for GxP impact and advise on appropriate validation strategies based on risk
- Collaborate with project teams to integrate compliance activities into project timelines and deliverables
- Lead or support the creation of validation documentation such as Validation Plans, Test Protocols, Traceability Matrices, Risk Assessments, and Validation Reports
- Review and approve system specifications, design documents, and test results to ensure alignment with quality standards
- Develop and maintain validation standards, templates, and training materials for internal teams
- Guide project teams in executing validation tasks correctly and efficiently
- Oversee formal testing processes, including planning, execution, documentation, and reporting
- Address validation issues, deviations, and change controls, ensuring compliant resolution
- Support change management by evaluating system modifications for re-validation needs
- Conduct periodic reviews to verify ongoing compliance and initiate re-validations as required
- Perform quality reviews of processes and deliverables to identify gaps and areas for improvement
- Monitor and report compliance KPIs to management
- Assess IT suppliers for reliability and compliance capability, influencing sourcing decisions
- Stay current with regulatory trends and emerging practices in computer system validation
- Serve as a subject matter expert for validation and compliance across the organization
Compensation & Work Environment
The position offers a monthly salary of at least 2000€, with potential for higher compensation based on experience and qualifications. A global incentive plan is available. The role is based in Slovakia with remote working flexibility.
