Process Support Specialist Role Summary:
Are you interested in supporting the manufacturing process? We are seeking a skilled Process Support Specialist to join our team.
This is an exciting opportunity to work on critical investment projects, both on-site and remotely. You will be responsible for:
* Supporting manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
* Providing input to the MES development process team on technical aspects of MES functionality and serving as MES SME within IPT
* Being a document system expert; this will include document review, approval, and document system workflow expedition.
* Formatting, writing, delivering, and reviewing necessary documentation in line with the standard approval process, and facilitating others to do so.
* Documents will include SOP's, SWI's, training documents, and change controls.
* Supporting 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.
* Supporting Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
* Raising CAPA's and conducting investigations. Raising and investigating quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implementing subsequent corrective action through the change management system.
Required Skills and Qualifications:
To be successful in this role, you will need:
* A Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
* Relevant experience and a particular skill set in your 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 the opportunity to work on critical investment projects and develop your skills and expertise in the field. As a Process Support Specialist, you will be part of a dynamic team and have the chance to make a real impact in the company.
Key Responsibilities:
In addition to the above responsibilities, you will also be expected to:
Requirements:
To be considered for this role, you must have:
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are looking for a challenging and rewarding role, we encourage you to apply now.