qa validation executive

Company: Smartedge IT Solutions
Job type: Contract
Industry: Information Technology

Role: QA Validation Executive (French Speaker)

Position: Contract

Location: Pringy, France.

Job-Related Experience :

 QA Validation Executive:

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 lifecycle 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

 

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