The right candidate should have a background with Computer System Validation according to FDA and EU regulations. That might include writing and execution of validation protocols (Installation Qualification, Operation Qualification, Performance Qualification), requirement specifications, and system change requests. Familiar with 21 CFR Part 11 and/or EU Annex 11 regulations
location: Raleigh, North Carolina
job type: Contract
salary: $55 - 65 per hour
work hours: 9am to 5pm
- Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
- Provide support for Business Technology's project portfolio within assigned area, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines.
- Coordinate assigned project deliverables with external consultants and suppliers concerning the implementation, validation, support and maintenance to ensure these activities are completed in alignment with standard compliance principles.
- Serve as subject matter expert in specialized area to support client and regulatory agency audits and inspections for Business Technology activities.
- Lead compliance efforts for any corrective or preventative actions plans supporting assigned Business Technology solutions.
- Assist in the review/harmonization of compliance work processes with those of other divisions when applicable.
- Act as a compliance resource expert to other groups.
- Assist internal clients with requests and problem resolution.
- Make recommendations for continued improvement in the area of compliance for Business Technology.