Quality SAP Master Data Specialist

Role: Quality SAP Master Data Specialist

Reports to: Quality Manager

Purpose:

SAP Quality Master Data is critical to product and patient safety as it drives quality control and testing requirements on each material. It drives what tests should be done on a material and by whom. Master data is critical to the core operations at the site. No master data or data set up incorrectly, could result in insufficient/incorrect testing performed on a material which could impact product or patient health and thus result in market recall.

The Quality Master Data Specialist will be responsible for managing, overseeing and leading initiatives for compliant, accurate and timely SAP master data to support flow of materials across the value stream which is enabled by SAP. The position holder will drive and foster an ethos of continuous improvement, provide direction and input to all project activities to ensure appropriate designs are captured from project initiation through to delivery. The Quality Master Data Specialist will work collaboratively with the Senior Manager, Quality Master Data to ensure the business goals and objectives of the Quality Master Data team and regulatory obligations as laid down by the FDA, EU and regional Ministries of Health are adhered to.

Responsibilities:

• Be an active member of the Quality Master Team to support the Company's succession planning.

• Sustain the culture of Quality across the Quality Master Data team.

• Foster a strong working relationship with relevant global functions as it relates to SAP master data and the performance of the company quality and compliance.

• Foster a strong working relationship with other master data stakeholders such as supply chain, procurement and operations.

• Participate in Master Data projects & coordinate with stakeholders to ensure master data milestones are met

• Manage & analyze workflow data requests for compliance, accuracy and completeness

• Follow robust procedures for the creation and approval of SAP Quality Views, Inspection plans, Quality Status records and Quality Information records.

• Create (where necessary) and approve all DSP master data requests relating to SAP Quality master data.

• Maintain SAP inspection plans for all incoming and manufactured materials

• Act as site SME for all SAP QA activities and benchmarking activities across the network such as DSP Approval, SAP Role mapping, Material Transfer and Control Records.

• Ensure quality focus is maintained in all team initiatives.

• Troubleshooting Quality issues with SAP as they arise relating to Inspection set up, Quality plans or quality status of materials.

• Creation of manual batches to allow for material to material transfers and re-processing.

• Creation and maintenance of Quality information records for vendor purchase.

• Accountable for tracking and achieving master data accuracy targets

• Assistance in resolution of master data related issues to ensure no interruption to the value stream.

• Manage Product On-Holds for non-conforming material.

• Management of Ship to Stock material master data.

• Attend weekly team meetings

• Represent the Quality Master data team at internal/external meetings as required and provide quality input/direction.

• Prepare, attend, and participate in business meetings for the site as required.

• Attend all meetings as required or arrange an appropriate deputy.

Qualifications:

• Degree or 3rd level qualification (Business, Science, Engineering)

• Advanced degree, diploma or certification in Data or Supply Chain Management preferred

• 3-5 years of SAP Master Data experience in the Manufacturing environment, preferably in the pharmaceutical industry

• Experience in setup of master data business processes

• SAP Master data experience should include excellent understanding of Material Master, purchasing, BOM, Routing, Quality etc.

• Possess analytical skills in data management, interpretation, and reporting

• In-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.

• Excellent communication & interpersonal skills that enable effective working relationships with internal/external stakeholders.

Provide the days of the week and the hours that this position will require:  

39 hours per week, not eligible for OT/DT

Please reach out to Joe Dawson on joe.dawson@cpl.ie or 061 208 132

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