Business Quality Representative
Core
Pilot operational quality assurance and Business Quality Representative (BQR) activities for IT systems across cross-functional departments at a vaccine production site.
Role type
Senior cross-functional quality representative (IT systems focus)
Builds
Operational quality assurance and IT system compliance for cross-functional functions
Domain
Biopharmaceutical manufacturing / Digital systems validation
Required skills
Pharmaceutical quality management, IT system validation (CSV), GxP compliance, Data integrity, Risk analysis, Change control management, Project lifecycle management
Preferred skills
CSV experience, Engineering degree
Technologies
GAMP 5, FDA/EMA regulations, Office Pack
Responsibilities
Coordinate operational quality activities for cross-functional support functions, Act as quality representative for cross-functional services and associated IT BQR, Manage anomalies, CAPA, and CCR, Approve quality and technical documents, Participate in field quality routines and audits, Prepare for site inspections and audits
