We are seeking a highly skilled Document System Expert to join our team in Carlow, Ireland. This exciting opportunity is ideal for individuals who thrive in dynamic environments and are passionate about delivering excellence.
Duties
* As a Document System Expert, you will be responsible for reviewing, approving, and expediting document workflow processes. You will format, write, deliver, and review necessary documentation in line with our standard approval process. This includes SOPs, SWIs, training documents, and change controls.
* You will support operation activities through documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases, including the process documentation system.
* Additionally, you will support batch release by completing timely Quality Notification completion, Interim/Summary report generation, and meeting batch release requirements.
* You will raise CAPAs and conduct investigations using standard tools and methods, such as FMEA, Fishbone diagrams, and 5 Whys, to resolve system issues and implement corrective action through the change management system.
* Furthermore, you will complete customer complaint investigations and Change Controls, ensuring they are closed out in a timely manner in conjunction with the SCM team.
As a Document System Expert, you must comply with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Education & Experience
* A Bachelor's Degree or higher in a Science, Engineering, or Technical discipline is preferred.
* SAP knowledge and experience are required.
* Strong report, standards, and policy writing skills are essential.
* Experience with equipment and process validation, sterile filling processes and equipment, and Lean Six Sigma Methodology is desired.