Job Description
- Design, develop, and execute Computer System Validation (CSV) protocols (IQ/OQ/PQ) to ensure that software systems meet FDA 21 CFR Part 11, GxP, and other regulatory requirements.
- Prepare and maintain Validation Master Plans (VMP), Risk Assessments, Requirements Traceability Matrices (RTM), and validation summary reports.
- Review and approve Standard Operating Procedures (SOPs), validation protocols, and test cases to ensure compliance with global quality standards.
- Provide consulting and guidance on quality and compliance need to IT project teams and enable them to achieve compliance using a risk-based approach.
- Perform Regulatory Compliance and Software Validation related activities.
- Author technical documentation using MS Office Suite and Document management tool GeodIS.
- Perform Change Management using Change Management tool.
- Performing risk assessments for change control active System integration and validation testing for new/enhanced web applications Testing of data integration.
Job Requirements
- Bachelor’s degree
- Send resume to: abdul@marstechnominds.com including the JOB ID.
- Travel and relocation to various unanticipated client locations throughout the United States may be required.
- Equal Opportunity Employer.
- Job Category : Software
- Job Type : Full Time
- Job Location : USA