quality systems coordinator.

Job Description Summary

Reporting to the Senior Quality System Coordinator or the Quality Leaders for each business team department. Responsible for the maintenance and control of the Quality Document Management System (SAP ECC6), and all matters related to documentation within the quality system. Processing of internal customer requests, in relation to document creation, management, distribution and filing.

Job Description

Main contact for the Plymouth plant for SAP ECC6 improvements and activities.
Liaising with FLKS document control contacts and project leaders when required for projects impacting Plymouth documents.
Attend ACR ECRO Strategy meetings as required.
To actively work with local project coordinators, advising on relevant documentation impacts.
Maintenance of all Device Master Specifications (DMS) for Plymouth PAS.
Maintaining the Plymouth document/ECO (Engineering Change Order) approval list for the Vacutainer business.
To maintain all Plymouth document templates within SAP ECC6 and the Plymouth system, creating new and updating when required.
Review and co-ordinate the approval of all Plymouth's ECO packages, ensuring accurate change control.
Issue of new document numbers.
To ensure that all documents are formatted and maintained to the company specifications.
Notifying appropriate personnel of document release including forwarding release notifications from other plants
Ensuring all new documents are communicated to the training department for addition to the relevant C2C curricula.
The implementation of all document changes within the SAP system, creating and maintaining document structures. In a method that is compliant with the 21CFR Part 11 regulation.
Update and maintain document control spreadsheets/databases in a timely manner.
Administration of EDOCs database document and User listings, editing, updating and troubleshooting as necessary.
Maintaining DHR documentation packs and updating as required.
Maintain/support QN Summary and BOS Charts including set up new sheets each financial year.
Work with Training department to ensure that users have the correct SAP Work Process Roles they require.
Good numeracy and literacy skills, Ideally GCSE maths and English.
Qualification in typing/word processing is desirable.
Computer literacy, knowledge of Microsoft word and attention to detail is essential.
Good organisation and administration skills required for this job role.
Key stakeholder in projects regarding documents and have good communication skills with all levels of the organisation.
A good understanding of how the other modules interact with each other within ECC6 is desirable.