Qualified Person
Core
Certify medicinal products in accordance with EU GMP and marketing authorization requirements, ensuring product release and quality system effectiveness.
Role type
Qualified Person (QP) / Quality Assurance Lead
Builds
Certified medicinal products and APIs for global distribution
Domain
Pharmaceutical manufacturing / Regulatory Quality
Required skills
EU GMP certification, product disposition coordination, deviation investigation, quality system auditing, stability study review, equipment/process validation, contract manufacturing assessment, analytical method verification, MBR approval
Preferred skills
Prior QP listing on EU manufacturing license, combination product experience, product development introduction
Technologies
Trackwise, SAP, MES
Responsibilities
Certify medicinal products per EU Directive 2001/83/EC & 2001/20/EC; Coordinate QA duties for product disposition; Lead investigations on manufacturing deviations; Approve GMP declarations for APIs; Conduct self-inspections of quality system; Review stability studies and validation protocols; Assess contract manufacturing facilities; Verify analytical test methods; Approve Marketing Authorization Holders (MBRs)
Seniority
Senior, hands-on IC
