Description
QA Validation Executive needed for major client
A major client in France is in need of QA Validation Executives for a new project.
Role includes:
Provides expertise and guidance to the project team on computerized system validation activities to meet GxP regulatory needs using a risk based approach.
Assess Project Team Qualification (training curriculum) (mandatory for GXP and SOX projects) (21 CFR Part 11)
All documents reviewed and available in electronic document management and application life cycle tool
Review the Test strategy and Test documentations
Review infrastructure qualification project documentation
Provide Review Feedback
Ensure Knowledge management/transfer and inspection readiness
Training Delivery according to Procedures
Follow up of CAPA with the CAPA owners, check accuracy of when CAPA is closed
Third Parties Quality Management
Internal Control and Risk Management
Training calendar weekly monthly project specific
Predictive Compliance Planning and Remediation
Weekly and Monthly dashboards
Shift left compliance in SDLC
Facilitate Projects on SOP's for CSV
Review & Approvals of SDLC documentation in line with SDLC requirements
Ensure inspection readiness of the project
Skills preferred:
IT project Management in LS environment, GxP & SOX Regulatory
Computer System Validations, SOP Writing, 21 CFR Part 11 certificate, SDLC approach
Interviews are rolling now, apply soon to avoid disappointment.