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System Validation Specialist
2 weeks ago
We are seeking a highly skilled CSV Engineer to play a pivotal role in ensuring the reliability and compliance of our systems.
Key Responsibilities:
- Develop Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.
- Collaborate with IT, Quality Assurance, and Operations teams to ensure adherence to regulatory guidelines and internal policies.
- Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
- Create comprehensive validation documentation, including validation plans, test scripts, traceability matrices, and validation summary reports.
- Perform periodic reviews to ensure ongoing compliance.
- Participate in change control processes, assessing the impact of system changes and overseeing appropriate validation activities.
- Provide expert guidance and support to project teams on CSV principles, best practices, and regulatory expectations.
- Maintain knowledge of industry trends, regulatory changes, and advancements in computer system validation.
- Collaborate with vendors and suppliers to ensure third-party systems meet validation requirements.
- Support regulatory inspections and audits, providing necessary documentation and participating in direct discussions.
