QP (Qualified Person)
Core
Senior Quality Specialist acting as Qualified Person (QP) ensuring product quality and regulatory compliance for pharmaceutical manufacturing.
Role type
Senior IC Qualified Person (QP) / Quality Specialist
Builds
Pharmaceutical products for US and EU markets
Domain
Pharmaceutical manufacturing / GMP / Regulatory Compliance
Required skills
GMP compliance, batch certification, risk assessment, CAPA management, root cause analysis, regulatory audits, change control, EHS compliance
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 GMP adherence; support investigations and approve deviations; conduct audits and self-inspections; drive continuous improvement of QMS; maintain communication with clients.
Seniority
Senior, hands-on IC
