Process Support Specialist

2 days ago

Carlow, Ireland Quanta part of QCS Staffing Full time

Process Support Specialist - Pharmaceuticals - Carlow, Ireland - 11-Month Contract Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than people. They are looking to add to their team and require a Process Support Specialist. This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely. Role Summary: 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 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. Skills and Knowledge 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. Proficiency in Microsoft Office and job-related computer applications required. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required. Equipment and process validation Sterile filling processes and equipment Lean Six Sigma Methodology experience desired. If this role is of interest to you, please apply now   #LI-CH3

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