WE ARE HIRING

Biological QA Specialist + QP

Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause

Neuraxpharm is looking for a Biological QA Specialist + QP based in Barcelona

(hybrid role)

Your Mission

The Biological QA Specialist ensures end‑to‑end quality and regulatory compliance of assigned biological products manufactured by external CMOs, maintaining and improving the QA system in line with GMP, GDP and ICH guidelines. The role acts as the quality lifecycle expert—managing manufacturing and testing changes, resolving quality incidents, integrating new API sources, and ensuring market‑specific regulatory alignment while contributing to integral standards.

Your Major Accountabilities

Biological QA Specialist

Write, review and approve technical documents: SOPs, master batch manufacturing records, analytical methods, material lists,



specifications, stability studies, filed dossiers, Quality Agreements, environmental conditions, etc. coming from CMOs
Write, review, approve and monitor CAPAs, deviations, OOS, complaints, change controls etc.
Write, execute or review validation activities related to storage and distribution.
Write, execute or review qualifications (equipment, utilities and facilities) and validations (e.g. process, cleaning).
Write, review and approve Product Quality Review reports.
Perform Compliance checks (internal procedures vs filed documentation).
Execute internal and external audits. Attend inspections/audits from Health Authorities and customers.
Prepare and execute GMP trainings.
Attend requests regarding quality related to marketed products.
Participate on the assigned projects.

Qualified Person

Batch release of drug products; batch release for clinical trials; declaration of psychotropic substances; coordin

📌 Biological QA Specialist + QP (Sant Joan Despí)
🏢 Neuraxpharm
📍 Sant Joan Despí