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Global Quality Documentation Specialist

Sanofi
Hungaryfull_timeVerifiedPosted 23 Oct 2024

About the role

  • Location: Budapest  

 

About the job 

 

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.  

 

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. 

 

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. 

 

Main responsibilities: 

  • Execute administration and governance related tasks: 
  • Mapping (per doc package) & process navigator update 
  • Update QualiPSO parameters related to CMS process: stakeholders review list, picklists, … 
  • Support the coordination of gap assessment process for global documents:  create gap analysis tables 
  • Management of definition of global glossary in the tool 
  • With a focus on initiation of quality documents (QD) deliverables 
  • Create DocID in QualiPSO and metadata: manage the creation & update of metadata 
  • Coordinate transversal Content Management System (CMS) QualiPSO administration  
  • Check global documents created by error (in the owning entity) – only global documents 
  • Check user access and privilege (care request management), training assignment and annual review access 
  • Support document change request (DCR) process – Monitoring of DCR process including KPI, DCR sharing for decision (to author and GQ Doc expert) 
  • Support periodic review by monitoring periodic revision process with KPI 
  • Support the weekly communication on Global Quality Document approval, and generate QualiPSO extraction on demand 
  • Support on CoBaz (ISO Normes platform) question, monitor and answer to site following new Normes requests, support on communication to GQDoc team 

 

About you  

Experience 

  • Approximately 1 year of professional experience in documentation or administration  
  • Experience in GxP environment would be a plus  

  

Soft and technical skills 

  • Proficient in problem-solving, attention to detail, and good organizational skills 
  • Ability to work collaboratively with cross-functional teams in a flexible and proactive manner
  • Strong analytical skills
  • Agile thinker and learner, adaptable to complex & dynamic environments 
  • Strong skills in Quality DMS, Word, Excel, PowerPoint 

 

Education: Minimum bachelor’s degr

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Company

Sanofi

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