Headcount Solutions is seeking a Documentation Specialist for our client’s biotech facility in Dublin. This role will be responsible for supporting the Quality Systems Department in the management of the site GMP documentation, and in supporting the Quality Assurance functions in various administrative duties.
· Responsible for the control, operation and maintenance of the site Central Documentation Control system
· Be a document system expert; this will include document generation, review, approval and document system workflow expedition e.g. SOP’s, Work Instructions, Reports
· Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
· Support site activities through documentation generation, filing, tracking, auditing. and maintenance of associated databases.
· Maintain the site archiving area, logging in new documents and logging out documents as requested following site procedures and practices.
· Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
· General audit preparation of documentation for audits (i.e. FDA, IMB, Corporate, Customer, etc).
· Presentation, compilation and review of data as directed.
· Degree in Science or related discipline.
· 2+ years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry.
· Supervisory experience preferable.
· Knowledge of EU/US quality related pharmaceutical regulations.