Job Description
We are seeking a highly skilled Document System Expert to join our Pharmaceutical organization in Carlow.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its field.
Duties and Responsibilities
* Document Management: Develop expertise in document systems, including review, approval, and workflow management. Create, format, write, deliver, and review necessary documentation in line with standard approval processes, ensuring others can do so efficiently.
* Operation Support: Generate documentation, file, track, audit, and maintain databases associated with process documentation systems. Ensure efficient maintenance, auditing, and archiving of these systems.
* Batch Release Support: Complete Quality Notification completion and Interim/summary report generation timely, meeting batch release requirements.
* Quality Assurance: Raise CAPAs, conduct investigations, and implement corrective actions through the change management system. Resolve system issues using standard tools and methods (e.g., FMEA, Fishbone diagrams, 5 why's).
* Customer Complaints and Change Controls: Investigate customer complaints and ensure they are closed out in a timely manner in conjunction with the SCM team.
* Regulatory Compliance: Comply with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities and job functions.
Education and Experience
* Qualifications: Bachelor's Degree or higher in Science, Engineering, or Technical discipline.
* SAP Knowledge: Required experience with SAP systems.
* Writing Skills: Report, standards, and policy writing skills are essential.
* Equipment Validation: Experience with equipment and process validation.
* Lean Six Sigma: Methodology experience desired.