
Data Validation Specialist
5 days ago
Job Title: Data Validation Specialist
We are seeking a skilled professional to lead validation and assurance efforts across critical systems.
About the Role:
- Lead validation and Computer Software Assurance (CSA) for IT and OT systems, ensuring compliance with regulatory standards.
- Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation) using GAMP/CSA methodology.
- Provide risk-based validation guidance aligned with industry requirements.
- Partner cross-functionally with QA, IT, Engineering, and Manufacturing teams.
- Support system and process improvements that enhance quality, compliance, and efficiency.
- Utilize tools like Excel and Minitab for data analysis and reporting.
Key Requirements:
- 5+ years of experience in computer system validation or software assurance in a regulated environment.
- Deep knowledge of 21 CFR Part 11, 21 CFR 820, ISO 13485, and GAMP/CSA methodology.
- Strong understanding of IT/OT systems, including MES, SCADA, ERP, LIMS, Data Historians.
- Proven experience developing validation plans, protocols, and risk assessments.
- Excellent communication and documentation skills.
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