Qualified Person
Core
Certify and release medicinal products ensuring compliance with EU GMP, Marketing Authorisations, and regulatory standards.
Role type
Senior Qualified Person (QP)
Builds
Certified medicinal product batches for consumer health brands
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
EU GMP expertise, batch certification, quality risk management, deviation/investigation handling, regulatory audit support, stakeholder collaboration
Preferred skills
PSI registration, Level 8 Science/Medical degree, leadership in regulated environments
Technologies
EU GMP, Quality Management Systems, HPRA regulations
Responsibilities
Certify and release medicinal products; Ensure batch compliance with Marketing Authorisations; Lead quality decision-making; Support investigations, deviations, and CAPA; Drive problem-solving to prevent quality issues; Act as key decision-maker on product quality; Support internal/external audits and regulatory interactions; Partner with cross-functional teams for timely release.
Seniority
Senior, hands-on IC
