Description
Quality Manager - Computerised System Validation (CSV)
Contract: long term duration
Location: working onsite with a client based in France (near to Geneva)
Quality Support to project
Provides expertise and guidance to the project team on computerised 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
Developing and promoting good practices to continuously improve the quality and effectiveness of the ITS processes, achieving the appropriate level of regulatory compliance, act in close partnership with all stakeholders to ensure consistency in quality approach
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:
IT project Management in LS environment, GxP & SOX Regulatory, Computer System Validations, SOP Writing, 21 CFR Part 11 certificate, SDLC approach
Training package:
CSV, SDLC