Process Support Specialist Opportunity
This is an exciting opportunity to be involved in the development and production of veterinary vaccines at a Centre of Excellence. As a Process Support Specialist, you will play a critical role in supporting manufacturing activities, documentation generation, equipment and process investigations, and quality notifications.
The successful candidate will have a Bachelor's Degree or higher in a Science, Engineering or Technical discipline, and relevant experience in a manufacturing setting, preferably GMP. SAP knowledge and experience are also required, as well as proficiency in Microsoft Office and job-related computer applications.
Key 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 workflow expedition.
* Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
* Documents will include SOPs, SWIs, 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 CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; implement subsequent corrective action through the change management system.