Beschreibung
Project to re-label products for the Russian market.Products are send from multiple sites around the World, are re-labled and delivered to the Russian distribution centre.
The IT workstream of the project is required to deliver the following capabilities:
• Management of logistics of product movement from distribution center to Hamburg and the end customer
• Generation of Russian specific label templates
• Collection of original manufacturing lot data from source systems
• Generation of Relabelling work orders in the site ERP system
• Control of the process in the existing site MES and label management systems
• Management of translation of original label content into Russian
• Transfer of content to the automated re-label and repack machine
• Provide a ‘Device History Record’ or the executed process for each work order
The project requires interfaces to be established to multiple systems and must be built and validated to the business SDLC and compliance requirements based on GMP guidelines. The IT system comprises multiple modules and changes to multiple on-site and off-site systems. The compliance plan calls for the execution of specific module test and full system integration validation tests co-ordinated with the overall project plan. In support of this we require the immediate recruitment of an experienced CSV validation professional as described below.
Task description
Familiarize with site SDLC and CSV standards and the project compliance plan
Work with the development team to support generation of GMP standard test scripts
Facilitate Review and Approve test scripts
Ensure document and version control systems are applied and used
Support execution of scripts and documentation and tracking resolution of defects
Facilitate Review and Approve of executed test scripts
Owning/controlling changes to the System Baseline Definition through all validation phases
Facilitate completion of the project validation report
Competencies Required
Fluent German and very good English (Required for both, written and spoken!!!)
Proficient in Adaptiv or similar document management system (Preferred)
Proficient in GMP and SDLC / CSV processes and standards (Required)
Experience in complex project execution (Required)
Technical Writer competences
Documented Software testing