Responsible Person
Core
Ensure EU Good Distribution Practice, national regulations, and Wholesalers Distribution Authorisation compliance to assure quality, safety, and traceability throughout the medicinal product supply chain.
Role type
Responsible Person (RP) for medicinal product distribution
Builds
Quality Management System for wholesale distribution of medicinal products
Domain
Pharmaceutical distribution / Regulatory compliance
Deliverable
client delivery
Required skills
GDP compliance, Quality Management System oversight, Quality Risk Management, Falsified Medicines Directive knowledge, Change Control assessment, Deviation and CAPA management, Recall operations, Supplier/Customer approval, Subcontracted activity approval, Self-inspection coordination, Product disposition decisions, Delegation management
Preferred skills
Pharmaceutical/Life Sciences/Engineering degree background, GDP setting experience
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint)
Responsibilities
Implement and maintain Quality Management System and GDP procedures; Apply Quality Risk Management principles; Participate in Quality Management Review Meetings; Assess and approve GDP Change Controls; Manage authorized activities and record accuracy; Implement training programs and track legislative changes; Coordinate recall operations and handle customer complaints; Approve suppliers, customers, and subcontracted activities; Perform self-inspections and corrective measures; Decide on final disposition of returned/rejected/recalled products; Delegate duties and manage performance.
Seniority
Mid-to-Senior level, hands-on regulatory role
