
Pharmaceutical Manufacturing Specialist
4 days ago
Key Responsibilities:
Process Support SpecialistWe are seeking a highly skilled Process Support Specialist to join our team. The successful candidate will be responsible for supporting manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
The role involves providing input to the MES development process team on technical aspects of MES functionality and serving as MES SME within IPT. The ideal candidate will have strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.
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 SOPs, SWIs, 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 CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods, such as FMEA, Fishbone diagrams, and 5 Why's; implement subsequent corrective actions 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 standards.
- Report, standards, policy writing skills required.
- Equipment and process validation.
- Sterile filling processes and equipment.
- Lean Six Sigma Methodology experience desired.
About this Role:
This is an exciting opportunity to be involved with critical investment projects both on-site and remotely. If you have a passion for pharmaceuticals and want to be part of a dynamic team, please apply now.
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