Tech Writer - Documentation Support

Seine-et-Marne  ‐ Onsite
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Description

Tech Writer - Documentation Support
Tech Writer - Documentation Support urgently required for interesting contract in France
6 month rolling contract based in France
The Tech Writer - Documentation Support will be Responsible for the following:

Provides expertise and guidance to the project team on Documentation of application to be upgraded(User Requirement, GxP assessment, Traceability Matrix, Functional Specification, .)
Provides support to meet GxP and 21 CFR Part 11 regulatory needs using a risk based approach
Provide Review Feedback

The Tech Writer - Documentation Support will ideally have the following skills and expertise:

All documents reviewed and available in Electronic Document Management and application Lifecycle tool
Create/Update/Review infrastructure and Administration documentation
Ensure Knowledge management/transfer
Developing and promoting good practices to continuously improve the Documentation and effectiveness of the ITS processes, achieving the appropriate level of regulatory compliance, act in close partnership with all stakeholders to ensure consistency of project documentation
Predictive Compliance Planning and Remediation
Weekly and Monthly dashboards
Shift left compliance in Application Development Lifecycle
Facilitate Projects on SOP's & Instruction Procedure for CSV
Review & Approvals of Application Development Lifecycle documentation in line with System Development Lifecycle requirements
IT project experience LS environment, GxP & SOX Regulatory, Computer System Validations (CSV), Instruction Procedure Writing, 21 CFR Part 11 certificate, System Development Lifecycle approach
Training package:
CSV, SDLC

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Start date
ASAP
From
Gazelle Global Consulting
Published at
19.01.2019
Project ID:
1704504
Contract type
Freelance
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