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Documentation Management Coordinator

3 weeks ago

Carlow, Ireland beBeeProcess Full time €45,000 - €60,000
Process Support Specialist

We are seeking a dedicated Process Support Specialist to collaborate with our team in Carlow. This opportunity is ideal for someone passionate about process improvement and documentation management.

  • As a document system expert, you will be responsible for reviewing, approving and expediting documents through the workflow. You will format, write, deliver and review necessary documentation according to the standard approval process, and facilitate others to do so. Documents may include SOP's, SWI's, training documents, and change controls.
  • You will 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.
  • You will support Batch release by completing timely Quality Notification, generating Interim/summary reports; meeting batch release requirements.
  • You will raise CAPA's and conduct investigations, raising and investigating 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.
  • You will 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.
  • You will maintain compliance with policies, procedures and guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Required Skills & Qualifications
  • 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