Found Description
- Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements.
- Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs.
- Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable.
- Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations.
- Support and assess documentation and system changes through formal change control and impact assessments.
- Identify current and future regulatory requirements for computerized systems and recommend stra...
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