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Job Description
Job Purpose: Generating and expediting review and approval processes for IPT GMP documentation including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.
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 work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases.
- 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.
- Complete Customer complaint investigations and Change Controls.
- Work collaboratively to drive a safe and compliant culture in Carlow.
Skills and Knowledge:
- Currently pursuing Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Proficiency in Microsoft Office and job related computer applications required.
- Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team-oriented manner.
- Excellent attention to detail.
Required Skills:
Analytical Problem Solving, Clinical Research, Data Analytics, Database Management, Data Entry, Data Visualization, Document Management, Health Economics, Office Applications, Process Improvements, Project Management, Reporting and Analysis, Technical Support, Technical Training, Workload Prioritization
Preferred Skills:
Current Employees and Current Contingent Workers apply internally.
Additional Information:
- Employee Status: Intern/Co-op (Fixed Term)
- Relocation: No relocation
- VISA Sponsorship: No
- Travel Requirements: No Travel Required
- Flexible Work Arrangements: Hybrid
- Shift: Not Indicated
- Valid Driving License: No
- Hazardous Material(s): N/A
- Job Posting End Date: 09/16/2026. A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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Job Description
Job Purpose: Generating and expediting review and approval processes for IPT GMP documentation including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.
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 work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases.
- 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.
- Complete Customer complaint investigations and Change Controls.
- Work collaboratively to drive a safe and compliant culture in Carlow.
Skills and Knowledge:
- Currently pursuing Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Proficiency in Microsoft Office and job related computer applications required.
- Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team-oriented manner.
- Excellent attention to detail.
Required Skills:
Analytical Problem Solving, Clinical Research, Data Analytics, Database Management, Data Entry, Data Visualization, Document Management, Health Economics, Office Applications, Process Improvements, Project Management, Reporting and Analysis, Technical Support, Technical Training, Workload Prioritization
Preferred Skills:
Current Employees and Current Contingent Workers apply internally.
Additional Information:
- Employee Status: Intern/Co-op (Fixed Term)
- Relocation: No relocation
- VISA Sponsorship: No
- Travel Requirements: No Travel Required
- Flexible Work Arrangements: Hybrid
- Shift: Not Indicated
- Valid Driving License: No
- Hazardous Material(s): N/A
- Job Posting End Date: 09/16/2026. A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
