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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

IPT Process Support Specialist (24/7 shift)


Reference:RK19635 Location: Carlow
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Process Engineer

IPT Process Support Specialist (24/7 shift)
RK19635
Contract – 11 months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
  • Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with 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.
  • Required to comply with Global 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.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required



Experience and Education:
  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting
  • SAP knowledge and experience required



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.