Regional Quality Documentation Specialist

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

• With a focus on initiation of quality documents (QD) deliverables
• Create DocID in QualiPSO and metadata: manage the creation & update of metadata
• Implement updates of applicability of the documents and stakeholders, update picklist (e.g. material, buildings, etc…)
• Implement communication strategy based on local document governance
• Coordinate transversal Content Management System (CMS) QualiPSO administration – check user access and privilege (care request management), training assignment and annual review access
• Support good documentation practices training and communication
• Support document change request (DCR) process – Support monitoring of DCR process including KPI, DCR sharing for decision (to author and local Doc Controllers)
• Support periodic review by monitoring periodic revision process with KPI, interaction with Author/local Doc Controllers, launch of periodic revision process in the tool
  
  

About You

• Experience: >1 yrs professional experience in documentation, in GxP environment ´
• Soft 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
• Technical skills: Strong skills in Quality DMS, Word, Excel, Powerpoint
• Education: Good administrative experience, Bachelor Degree preferrable
• Languages: Excellent English communication and writing
  
  

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