- 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.
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