Reporting directly to the SAP Quality Supervisor of Grifols Worldwide Operations (GWWO).
Responsibilities are to complete and support activities within the Quality Department relating to SAP in Grifols Worldwide Operations Ltd (GWWO) for manufacturing and packaging plants.
RESPONSIBILITIES
- Creation and maintenance of the Quality views for the material master data of all materials for procured, manufactured and packaged materials/product
- Creation and maintenance of master data for inspection plans for testing of raw materials, semi-finished product, finished product and associated processes, including environmental monitoring, lab equipment, etc.
- Liaising closely with the Grifols sister sites in relation to the creation of master data for material/product transfer
- Creation and maintenance of Standard Operating Procedures for all tasks associated with SAP activities
- Compliance with procedures relating to GMP/GDP and other site procedures assigned
- Providing various reports from SAP to support the Quality Function at GWWO
- Providing timely and pro-active SAP support in various SAP GWWO projects
- Delivery of training in SAP for new employees, if required
- Participation in the completion of Deviation, CAPA and Change Control processes, as required
- Other duties as instructed by the SAP Quality Supervisor/ Quality Systems and Compliance Manager/ Technical Director.
In addition, the successful applicant will have the following.
- Previous experience in working the pharmaceutical GMP or medical devices environment.
- Good problem solving and continuous improvement skills
- Ability to work accurately under pressure
- Ability to handle multiple tasks and deadlines
- Good communication skills and the ability to collaborate at a variety of levels within and outside the organisation
- Ability to work on own initiative
- Proven success working well in a team environment with flexibility to react to changing business needs, as well as demonstrated problem solving and project management ability.
- Minimum of B.Sc Degree or equivalent third level education and at least 3 years' experience in quality within the pharmaceutical/medical devices industry.
REQUIREMENTS
Experience in SAP ECC as a Quality end user is preferred.
Experience in SAP Quality Management (QM) module is desired but not essential. Training can be provided in this field.
A strong background in Quality Control and Quality Assurance is essential.
Advanced knowledge of Excel is desired.
A deep knowledge and understanding of the Data integrity requirements is desired.