Onyx is now licensed to manufacture commercial API from our UK facility

Document Controller GMP

The Role

We are a medium size early phase Pharmaceutical CRO which require a Document Controller for the GMP Department after a recent expansion. You will need to be able to prioritise your own workload, meet tight schedules and business deadlines. 

We are looking for a document controller with good knowledge of Sharepoint/Dropbox management systems, project compliance and procedures, preferably gained within a Chemistry/ Quality /Analytical environment.

Key Responsibilities

  • You will be the responsible for the control of GMP documents from initial writing, through revision, up to issuing of the documents for use. 
  • Receipt and logging of project documentation, maintaining document registers and numbering systems
  • Managing the flow of documentation within the organisation, including workflow approvals, sign offs and revision/version control
  • Distributing and Managing the flow of documentation via clients for review and signature 
  • Data Management and cleansing activities to ensure accuracy and completeness
  • Providing an accurate and up-to-date status of the information/document flow whenever requested
  • Regularly auditing company systems to ensure correct and accurate usage
  • Copying, scanning and storing documents and retrieve as required
  • Creating templates for future use
  • Maintaining confidentiality around sensitive information and terms of agreement
  • Preparing ad-hoc reports on projects as needed
  • Assisting the Management Team in the production monthly report

About You

  • Strong competence using Microsoft Office including Sharepoint, Teams and Dropbox.
  • Proficient with other MS Office software, Excel and Word etc.
  • Knowledge of quality assurance processes applicable to document management
  • Preferably experience of working within a GMP environment
  • Proactive and assertive for chasing and expediting documents
  • A “can do” motivated approach to problem solving
  • A keen eye for detail with exceptional organisational skills
  • An individual with a team mentality who is capable of collaborative working
  • Ability to work in technical environment with conflicting priorities and constraint

 


Apply for the position of Document Controller GMP