Job Description
This is a fantastic opportunity to be involved in the creation and maintenance of critical documentation for manufacturing activities, both on-site and remotely.
Main Responsibilities:
* Generate documentation associated with non-GMP activities and complete quality notifications in a timely manner.
* Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
* Be an expert in document systems, including document review, approval, and workflow expedition.
* Format, write, deliver, and review necessary documentation in line with standard approval processes and facilitate others to do so.
* Documents will include SOP's, SWI's, training documents, and change controls.
* Support operational 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 CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods to resolve system issues; implement subsequent corrective action 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 Codes, Standards and Practices.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Lean Six Sigma Methodology experience desired.