Qualified Person and Responsible Person - UK
Core
Ensure compliance with UK Good Distribution Practice (GDP) for the importation, storage, transportation, and distribution of medicinal products.
Role type
Responsible Person (RP) / Qualified Person (QP) for pharmaceutical distribution
Builds
Maintains the Wholesale Distribution Authorization (WDA) and ensures GDP compliance for European-manufactured products stored/transported in the UK
Domain
Pharmaceutical industry / Regulatory Compliance / Supply Chain
Deliverable
client delivery
Required skills
GMP/GDP expertise, auditing and compliance knowledge, analytical decision making, stakeholder management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Implement and maintain the GDP Quality Management System (QMS), authorize all quality-related activities and records, coordinate product recalls, manage distribution-related deviations and customer complaints, approve suppliers and outsourced activities, manage self-inspection programs and CAPAs, handle returned/rejected/recalled/falsified products, report medicinal product shortages
Seniority
Senior, hands-on IC