Job Summary
This is an exciting opportunity with a leading Pharmaceutical organization in Carlow. We are seeking a highly skilled individual to join our team as a document system expert.
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Key Responsibilities
* Be a document system expert, responsible for document review, approval and workflow expedition.
* Format, write, deliver and review necessary documentation according to the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls.
* Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
* Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
* Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
* Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
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Requirements
* Bachelor's Degree or higher preferred, ideally in a Science, Engineering or other Technical discipline.
* SAP knowledge and experience required.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Lean Six Sigma Methodology experience desired.