Quality Operations Supervisor
Core
Lead QA Operations team to ensure GMP compliance, document review, and quality oversight on the manufacturing floor.
Role type
Senior IC Quality Operations Supervisor (Shift Lead)
Builds
Quality assurance processes and documentation for drug product manufacturing
Domain
Pharmaceutical manufacturing / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, document review, deviation/CAPA management, risk management, team leadership, audit participation, data integrity, change control, batch record review
Preferred skills
sterile manufacturing experience, continuous improvement (Kaizen/Mini Transformations), project delivery, business strategy influence
Technologies
Eudralex Volume 4, 21CFR part 210/211
Responsibilities
Supervise document review for batch release, resolve significant quality issues, approve deviations/CAPAs/change controls, conduct internal audits, oversee data integrity, manage shift handovers, lead continuous improvement initiatives, monitor team training and competency
Seniority
Senior, hands-on IC with people management