Join Our Pharmaceutical Team
We are currently seeking a highly skilled Process Support Specialist to join our team in Carlow, Ireland. This is an exciting opportunity to be involved in the development and production of veterinary vaccines for a leading pharmaceutical company.
This 11-month contract role will provide you with the chance to work on critical investment projects both on-site and remotely. You will have the opportunity to support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
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 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.
Required Skills and Qualifications:
* 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.
Benefits:
This role offers a fantastic opportunity to be part of a dynamic team and contribute to the success of our pharmaceutical client. You will have the chance to work on exciting projects and develop your skills and expertise in a fast-paced environment.
Others:
Please note that this is an 11-month contract role and candidates must have the right to work in Ireland.
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