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Quality Documentation Specialist

London, United Kingdom

  • Salary: Up to £170 per day
  • Job type: Interim/Contract
  • Posted: 23/11/2018
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 3794

Job description

To support the Document Management System, including the uploading, routing, reviewing, approving, issuing and obsoleting of quality documents. To provide training and user support to all users of the document management system. 

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