Our pharmaceutical client is a Centre of Excellence, employing over people. They seek to add to their team with a Process Support Specialist. This opportunity allows for involvement in critical investment projects both on-site and remotely.
Job 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.
Requirements:
* 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.
This role requires a strong understanding of Manufacturing Execution Systems (MES) and Document Management Systems (DMS). The ideal candidate should have excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
The successful candidate will be able to demonstrate a high level of autonomy, with the ability to work independently and make decisions with minimal supervision. They should also be highly organized, with strong time management skills and the ability to prioritize tasks effectively.
We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development. If you are a motivated and enthusiastic individual who is passionate about working in a fast-paced and dynamic environment, please submit your application.