Qualified Person
Core
Responsible for the EU release of imported pharmaceutical products and active substances, ensuring compliance with EU GMP regulations and quality management systems.
Role type
Qualified Person (QP) for pharmaceutical import release
Builds
Ensures regulatory compliance and quality release of imported medicines for the EU market
Domain
Pharmaceutical industry / Regulatory Quality Assurance
Deliverable
client delivery
Required skills
EU GMP knowledge, QP certification, deviation management, OOS handling, change control coordination, audit support, quality system development
Preferred skills
Import release experience, sterile manufacturing experience
Technologies
GMP documentation systems, quality management software
Responsibilities
Review and approve manufacturing and quality documentation prior to release, coordinate with foreign manufacturing sites, manage deviations and change controls, support audits and regulatory inspections, continuously develop the quality management system
Seniority
Mid-level, hands-on specialist
