Manufacturing documentation specialist

Key Responsibilities:

* Support operational excellence through meticulous documentation generation, thorough equipment and process investigations related to non-compliance activities and completion of quality notifications.
* Collaborate with the MES development team on technical aspects of MES functionality and serve as MES subject matter expert within IPT
* Be a document management expert; this will include document review, approval, and document workflow expedition.
* Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
* Documents will include SOP's, SWI's, training documents, and change controls.
* Ensure smooth operation activities through timely 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 Corrective Actions 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.

* 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 setting.
* SAP knowledge and experience required.
* Proficiency in Microsoft Office and job-related computer applications required.
* Knowledge of regulatory/code requirements to 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.

This is an excellent opportunity to be involved with the critical investment projects both on-site and remotely. As a Process Support Specialist, you will be part of a talented team that employs over people worldwide.

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