Biological QA Specialist & Qualified Person (QP)
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Actual Talent is the talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.
Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people diversity and inclusion innovation and cutting-edge technology.
The role:
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 launches.
Technical Depth: A role with significant responsibility in a specialized fast-growing biological portfolio.
