Business Quality Assurance (BQA)

BQA Role

The BQA is responsible for interacting with both the quality/business and IT organizations to ensure that the global IT systems meet the Quality Management System requirements and are in a GMP and CSQ validated and stable state. The role is also a customer liaison in the development of system training, enhancements, reports, bug fixes and trouble-shooting user's issues that arise.

• Perform GMP Assessments for IT Changes, Providing Change Feasibility Review (CFR) support for SAP and/or determine GMP/non-GMP impact for all system changes
• Perform Audit Trail assessments and Business Deviation Write Ups
• Participate in site assessment if needed. Provide additional support if global design does not meet site needs.
• Own requirements, Approve Test scripts, Approve Deviations and Business Changes
• Set priority for Fixes/Changes in partnership with Tech, determine Regression testing scope.
• Consult and Educate others on SAP Quality Processes (e.g. gap assessments, self inspection compliance, management review, SOPs on SOP, Change Control, and Deviation)
• Directly support the SAP validation processes to drive compliance and continuous improvement.
• Subject Matter Expert for cGMP's and QM business requirements for the SAP IT solution
• Represent business area requirements within SAP (and related solutions) and to influence future direction of QM module

• Knowledge of IT System Validation Requirements.
• Competency on quality processes executed in SAP (e.g., batch release, material receipt, material status)
• Understanding of master and transactional data used in SAP business process.
• Knowledge of foundational quality systems (e.g., deviations, change management, good documentation)