The CQV Implementation Engineer shall be responsible for transitioning the CQV approach from the current V-model approach to a Risked Based Verification (RBV) approach based on ASTM-E2500-13.
The primary responsibility of the role is to help create the new processes, generate a project plan for implementation, generate the required documents and update procedures and work instructions as required by the change.
Generate New Procedures:
URS Procedure and Templates
Engineering Change Control
System Level Impact Assessment
CQV Site Procedure
Engineering Procedures and Technical Templates
Project Management Procedures
Utilise CQV Expertise and Support Project Management Teams:
Align site process with corporate Policies and SOP’s
Define Engineering approach to critical systems projects
Define validation approach
Work with Risked Based Verification (RBV) transformation team to deliver transition from V-Model validation to RBV
Liase with QA to develop Vendor audit Requirements
Stake Holders: Senior Validation, Engineering and Quality Teams
Primary Degree in Engineering discipline
5-7 years’ experience in Validation / CQV
Comprehensive understanding of Risked Based Verification and ASTM-E2500-13 and relevant EU/FDA regulations
Understanding of Process Validation, Computer System Validation, SCADA Systems, CPV, Sterilization, Packaging Systems and related Technologies
Tagged as: Commissioning, Qualification & Validation (CQV) Engineer
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