Quality Unit Business Process Specialist
Core
Quality oversight of SAP processes, business rules, and systems to ensure compliance and identify improvement opportunities within a pharmaceutical manufacturing environment.
Role type
Quality Unit Business Process Specialist (SAP & Process Compliance)
Builds
Compliant production processes, master data, and quality unit business processes for medicines and vaccines.
Domain
Pharmaceutical manufacturing / Quality Assurance / SAP Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis (quality metrics) & product features (process controls)
Required skills
cGMP knowledge, SAP proficiency, process documentation, change control, CAPA, deviation investigation, root cause analysis, data integrity, regulatory compliance (FDA/CFR), technical writing
Preferred skills
Biologics experience, MES/LIMS familiarity, Lean Management, risk assessment tools, DMAIC, coaching
Technologies
SAP, MES, LIMS
Responsibilities
Oversee Production SAP use, business rules, and compliance including master data creation; Act as site Quality Consultant for SAP issues; Ensure adherence to procedures and FDA regulations for QC Master Data; Lead design and maintenance of quality unit business processes and SOPs; Train users on SAP business processes; Assist with QA Systems objects (deviations, change controls, CAPA); Monitor quality metrics and recommend process improvements.
Seniority
Mid-level, hands-on IC
