Job Description
This engagement is being conducted on a personal capacity basis. We are seeking an experienced Computer System Validation (CSV) Subject Matter Expert (SME) to provide advisory support during the development of CSV SOPs and policies for a regulated life sciences environment. Documentation will be written internally; the consultant will provide recommendations to ensure alignment with regulatory expectations and industry best practices, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and CSA principles.
All materials and discussions will be treated as confidential, and the selected consultant may be required to sign a Non-Disclosure Agreement (NDA) prior to project start.
Contract duration of less than 1 month. with 10 hours per week.
Mandatory skills: Regulatory Compliance, Compliance Training, Compliance Consultation, Technical Documentation, Compliance Testing, IT Compliance Audit, Design Validation, Compliance, Pharmaceutical Industry, Project Management, Medical Device
All materials and discussions will be treated as confidential, and the selected consultant may be required to sign a Non-Disclosure Agreement (NDA) prior to project start.
Contract duration of less than 1 month. with 10 hours per week.
Mandatory skills: Regulatory Compliance, Compliance Training, Compliance Consultation, Technical Documentation, Compliance Testing, IT Compliance Audit, Design Validation, Compliance, Pharmaceutical Industry, Project Management, Medical Device
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