SAP Quality Senior Specialist
SAP Quality Senior Specialist
Reporting directly to the SAP Quality Supervisor of Grifols Worldwide Operations (GWWO).
To complete and support activities within the Quality Department relating to SAP in Grifols Worldwide Operations Ltd (GWWO) for the site.
- To be key user in working groups and to represent GWWO Quality on topics relating with Quality SAP, as requested.
- To represent Quality SAP as key user in Risk Assessment activity
- To be involved in periodic reviews of the SAP system to ensure compliance with roles and functionality
- Provide Quality SAP support to the Global Supply Chain, New Product Introduction (NPI) team.
- Provide Quality support for Deviations and CAPAs and to oversee the development and implementation of all associated activities
- Monitor compliance to regulations and GWWO/Global procedures and communicate CAPAs and action plans to Quality SAP Supervisor
- Support inspection readiness and the execution of audits/inspections; work with cross-functional colleagues to analyse risks and input into the inspection readiness strategy.
- Identify and recommend improvements to policies, processes, and systems to mitigate risks in the SAP Quality functionality.
- Ensure integrity of quality metrics extracted from SAP-QM by building a support and coaching structure for key personnel
- To represent GWWO Quality in improvements and enhancements to the SAP-QM module. To provide training in the improvements/enhancements to the required GWWO personnel.
- Provide Quality SAP technical support for the execution of validation & qualification activities relating to the SAP-QM improvements/enhancements.
- Responsible for the preparation of Quality Management metrics and support to Quality, as required.
In addition to the above responsibilities, the SAP Quality Senior Specialist will perform the duties of the SAP Quality Specialist, including, but not limited to;
- Engage with relevant stakeholders to support the creation and maintenance of material master data for Quality for incoming packaging materials, raw materials, semi-finished products and finished products
- Creation and maintenance of master data for inspection plans for testing of incoming packaging materials, raw materials, semi-finished product, finished products, water and in process testing within the Quality Control laboratories in GWWO
- Ensuring consistent approach to qualification, change control and deviation management across systems.
- Providing timely and pro-active SAP support in various SAP GWWO projects and guidance to facilitate project timelines
- Running different reports to support the Quality Function at GWWO
- Liaising closely with the Grifols sister sites in relation to the creation of master data for material/product transfer
- Represent the Quality Department at relevant GWWO site meetings and sister site meetings regarding the SAP projects/ inputs
- Training of relevant personnel in the basics of the SAP system.
- Training of new Quality personnel in SAP, if required
- Comply GWWO procedures relating to GMP/GDP and other site procedures assigned
- Supporting external projects that involves SAP Quality processes and functionality
- Other duties as required by the Technical Director/Quality Systems and Compliance Manager/SAP Quality Supervisor
- Proficiency in SAP and advanced knowledge of Excel.
- Previous experience working in the pharmaceutical GMP or medical devices environment.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Minimum of B.Sc Degree or equivalent third level education and at least 5 years' experience in quality within the pharmaceutical/medical devices industry.
- A deep knowledge and understanding of Data Integrity requirements.
- Strong SAP skills ideally in management of quality master data
- Good problem solving and continuous improvement skills
- Ability to work accurately under pressure
- Ability to handle multiple projects 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.
- Demonstrated project management skills
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Ability to influence senior management, peers, and other colleagues without direct reporting lines
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- Ability to multi-task and prioritise work
- Strong organisational ability