Specialist QA/QP (Plant QA)
Core
Release finished drug product lots and ensure compliance with marketing authorization and Good Manufacturing Practices (GMP) for medicines manufactured at the Breda plant.
Role type
Specialist Qualified Person (Plant QA)
Builds
Finished drug products for global distribution
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, risk analysis, document approval (SOPs, CAPA, deviations), change control impact assessment, equipment maintenance review, test protocol approval, regulatory inspection participation, validation document review, scientific problem solving
Preferred skills
EU directive 2001/83/EC article 49 knowledge, clinical and commercial manufacturing process knowledge, warehousing and supply chain knowledge, equipment engineering principles
Technologies
None stated
Responsibilities
Partner with production staff on risk analysis and quality limits; own and approve production/QA documents; review and approve deviations and CAPA; perform impact assessments for change controls; review maintenance work orders; approve test protocols; perform GMP compliance checks; participate in internal and regulatory audits; lead QA projects and investigations; assist in validation activities
Seniority
Specialist, hands-on IC
