Process Support Specialist - Pharmaceuticals
Do you want to be involved with exciting Pharmaceutical projects?
Our client, a Centre of Excellence in the pharmaceutical industry, is looking for a Process Support Specialist to join their team.
This is an excellent opportunity to be part of critical investment projects both on-site and remotely.
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.
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.
About the Company:
Our client is a leading pharmaceutical company with a global presence. They have a strong commitment to innovation and excellence, and are dedicated to making a positive impact on people's lives.