QA Document controller

Job description


  • The Document Controller will manage the preparing, issuing and controlling of GMP documents in the document management system to ensure consistent standards of presentations/formatting are met.
  • Format, write, deliver and review necessary documentation in accordance with the approval process, as well as facilitate others to do so. 
  • Carry out the Business System Administration role in the documentation management system.
  • Ensuring all document training is carried out as required. 
  • Produce monthly key performance indicator (KPIs) on document control systems as required.
  • Maintain document control software packages including; controlled documents database.
  • The Document Controller will develop and maintain the document archiving system.
  • Provide training to personnel and contract personnel as directed by the Quality Systems Executive
  • Assist implementation of global standards and procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Document Management System and supporting systems.
  • Provide support for regulatory submissions through collation and compilation of documents for inclusion in filings or presentation to auditors as required. 
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality
  • Participate fully in any cross functional training initiatives.
  • Ensure timely completion of all SOP, reading, training and assessment.


  • The document controller will have a BSc. in a scientific discipline and 4 years quality experience in the Pharmaceutical industry.
  • Experienced with finished product pharmaceuticals or biologics, including analytical chemistry, QA, QC, development, manufacturing areas.
  • The ideal candidate should have an in depth understanding of quality systems as well as cGMPs.
  • Excellent verbal and written communication skills.


Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.