Job Description
On behalf of an international pharmaceutical group, we are seeking a Biological QA Specialist & Qualified Person (QP) to join their Corporate Quality team in Spain. Reporting to the Quality Lead of Biologics , the successful candidate will ensure GMP/GDP compliance for medicinal products manufactured by external CMOs. This is a technical, hands-on role focused on the lifecycle management of biological molecules and high-profile global launches. Key responsabilities: Batch Certification: Act as the Qualified Person for the GMP release of biological drug products (commercial and clinical trials). CMO Oversight: Supervise quality standards and production processes at external manufacturing sites. Quality Events: Manage a high volume of Change Controls, Deviations, CAPAs, and OOS, ensuring technical issues in production are resolved. Documentation: Review and approve Master Batch Records, analytical methods, validation protocols (process/cleaning), and Quality Agreements. Health Authoritie...