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 Authorities: Serve as the primary point of contact for quality topics and coordinate batch recalls if necessary.
Candidate Profile
* Education: University Degree in Pharmacy (essential for QP status in Spain).
* QP Experience: At least 1 year of experience as a Qualified Person (or Deputy) specifically with biological products (e.g., monoclonal antibodies).
* Technical Background: 2-5 years in QA. Strong preference for candidates with prior experience in Manufacturing (Bioreactors) or Quality Control (QC).
* Languages: Proficiency in English and Spanish.
* Mindset: Analytical, process-oriented and capable of managing complex dossiers.
What is Offered
* Global Impact: Lead the quality strategy for major worldwide l aunches.
* Technical Depth: A role with significant responsibility in a specialized, fast-growing biological portfolio.