QP (Qualified Person)
Core
Ensure product quality and regulatory compliance for pharmaceutical and scientific operations, specifically leading batch certification and disposition.
Role type
Senior Qualified Person (QP) / Regulatory Quality Lead
Builds
Pharmaceutical products released to the US market
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch certification and disposition, GMP compliance, risk assessment, CAPA management, root cause analysis, regulatory audit support, change control, QMS maintenance, client communication
Preferred skills
Hosting regulatory inspections, customer audits
Technologies
Eudralex Volume 4, UK Orange Guide, US CFRs
Responsibilities
Conduct batch certification and disposition per EU regulations; ensure manufacturing adherence to GMP and site procedures; stay updated with international regulatory guidance; conduct audits, self-inspections, and spot checks; support investigations and approve major/critical deviations; drive continuous improvement of the QMS; establish communication with clients to align expectations
Seniority
Senior, hands-on IC