Quality Documentation Specialist

On Application
27 Nov 2018
27 Dec 2018
Quality, QA / QC
Contract Type

Quality Documentation Specialist

Role and Responsibilities: 

Affiliate Document Management System (DMS) 

  • Act as administrator and superuser of the electronic DMS 
  • Support subject matter experts with the management of documentation in the electronic DMS 
  • Ensure documentation complies with established electronic documentation system standards and document management policies 
  • Provide timely and efficient support to the documentation system users in handling document workflows and document change request 
  • Monitor progress of documents in workflows, ensure timely follow up and completion 
  • Proactively manage the quality documents periodic review process 

Archive management 

  • Ensure documentation and records are archived and retained in compliance with company policies 
  • Provide support and guidance regarding general document management and records archiving process 

QMS training 

  • In coordination with the Quality and Compliance Training Manager ensure appropriate document management system training is delivered and recorded for relevant personnel in the affiliate and relevant third parties. 
  • Support employee on-boarding by providing new hire training on the document management system 

Monitoring and audit/inspection readiness 

  • Provide support for internal/external audits/inspections for the UK/Ireland Affiliate in relation to the document management system 
  • Report relevant document management system metrics to the affiliate management team and other relevant internal stakeholders 

Internal affiliate Development (Culture) 

  • Work with the Quality team to continuously educate the affiliate on the importance of “quality” management and facilitate implementation of best practices 
  • Identify process gaps and solutions by continual review of existing Celgene compliance-related Quality processes (global, regional and local) 

Skills and Knowledge Requirements: 

  • Established knowledge of quality management principles and systems 
  • Excellent communication and collaboration skills 
  • Experience in delivering training and providing ongoing user support 
  • Solution orientated 
  • Highly organised and efficient 
  • Able to multi-task whilst maintaining a very high level of accuracy and attention to detail 
  • Excellent written and verbal communication skills 
  • Experience of supporting audits and internal quality/compliance reviews 
  • Life science/pharmacy degree 
  • A professional qualification in Quality &/or auditing would be advantageous 


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