We are currently recruiting for an exciting opportunity with a leading pharmaceutical organization based in Ireland.
Duties
* As a document system expert, you will be responsible for reviewing, approving and expediting document workflows. This includes formatting, writing, delivering and reviewing necessary documentation in line with the standard approval process. You will also facilitate others to do so.
* The documents you will work with include SOPs, SWIs, training documents and change controls.
* You will support operation activities through documentation generation, filing, tracking, auditing and maintaining associated databases.
* This includes maintaining, auditing and archiving the process documentation system.
* You will also support batch release by completing timely quality notifications, generating interim/summary reports and meeting batch release requirements.
* Raise CAPAs and conduct investigations using standard tools and methods, such as FMEA, Fishbone diagrams and 5 Whys.
* You will implement corrective action through the change management system.
* You will complete customer complaint investigations and change controls and ensure they are closed out in a timely manner in conjunction with the SCM team.
Requirements
* Bachelor's degree or higher in a science, engineering or technical discipline.
* SAP knowledge and experience is required.
* You must have report, standards and policy writing skills.
* Equipment and process validation experience is also required.
* Familiarity with sterile filling processes and equipment is preferred.
* Lean Six Sigma methodology experience is desired.