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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Process Support Specialist


Reference:AMC20346 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Process Technician

Process Support Specialist
11 month contract
On-Site Carlow
Shift work

In this role you will be responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.

This is the perfect role for somone who has been working in operations and is looking to get into a QA role down the line.

Responsibilities

  • 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. 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.

Requirements
  • Bachelors degree in Science, Engineering or Technical discipline
  • GMP manufacturing experience including SAP knowledge
  • Quality and Production Documentation experience (bonus)
  • Sterile manufacturing experience (bonus)
  • Ability to work shifts including nights and weekends