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 (QP) / Plant QA
Builds
Finished drug products for global distribution
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP compliance, risk analysis, document approval (SOPs, CAPA, deviations), change control impact assessment, equipment maintenance review, test protocol approval, internal audit leadership, regulatory inspection participation, validation document review, scientific problem solving
Preferred skills
Technical writing, presentation skills, collaboration with production and engineering staff
Technologies
GMP, EU directive 2001/83/EC, validation processes
Responsibilities
Partner with production 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; Conduct GMP compliance checks; Lead internal audits; Participate in regulatory inspections; Lead GMP training initiatives; Lead QA projects and investigations; Assist in validation activities
Seniority
Specialist, hands-on IC
