We are seeking an exceptional individual to join our Pharmaceutical organization in Carlow. This is a fantastic opportunity for someone looking to work with a leading multinational company that excels in its field.
Duties:
* As a document system expert, you will be responsible for reviewing, approving and facilitating the workflow of documents within our system. This includes formatting, writing, delivering and reviewing necessary documentation according to our standard approval process, as well as assisting others in doing so. Documents may include SOPs, SWIs, training materials, and change controls.
* You will support operational activities by generating, filing, tracking, auditing, and maintaining all associated databases, including the maintenance, auditing, and archiving of our process documentation system.
* Your responsibilities will also include supporting batch release through timely Quality Notification completion, interim/summary report generation, and meeting batch release requirements.
* You will be required to raise CAPAs and conduct investigations, using standard tools and methods to resolve system issues, such as FMEA, Fishbone diagrams, and 5 whys, and implement subsequent corrective action through our change management system.
* You will complete customer complaint investigations and Change Controls, ensuring they are closed out in a timely manner in conjunction with our SCM team.
* You must comply with Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of your daily activities and all applicable job functions.
Education & Experience:
* A Bachelor's Degree or higher is preferred, ideally in a Science, Engineering, or other Technical discipline.
* SAP knowledge and experience are required.
* Report, standards, policy writing skills are essential.
* Experience with equipment and process validation, sterile filling processes, and equipment, as well as Lean Six Sigma Methodology, are desired.