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QA Document controller

Job description

JOB RESPONSIBILITIES;

  • 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.

JOB REQUIREMENTS;

  • 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.

 

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