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.
Actual Talent