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Business Quality Assurance (BQA)

Business Quality Assurance (BQA)

ClifyXIndianapolis, IN, United States
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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.

Key Objectives / Deliverables :

  • 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

Experience :

  • 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)
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