Hybrid Biological QA Specialist, Qualified Person (QP)

Posted 4 days ago

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About the role

  • Biological QA Specialist ensuring GMP/GDP compliance for medicinal products. Leading quality strategy for global launches at an international pharmaceutical group.

Responsibilities

  • Act as the Qualified Person for the GMP release of biological drug products (commercial and clinical trials).
  • Supervise quality standards and production processes at external manufacturing sites.
  • Manage a high volume of Change Controls, Deviations, CAPAs, and OOS.
  • Review and approve Master Batch Records, analytical methods, validation protocols, and Quality Agreements.
  • Serve as the primary point of contact for quality topics and coordinate batch recalls if necessary.

Requirements

  • University Degree in Pharmacy (essential for QP status in Spain).
  • At least 1 year of experience as a Qualified Person (or Deputy) specifically with biological products (e.g., monoclonal antibodies).
  • 2-5 years in QA.
  • Strong preference for candidates with prior experience in Manufacturing (Bioreactors) or Quality Control (QC).
  • Proficiency in English and Spanish.
  • Analytical, process-oriented and capable of managing complex dossiers.

Benefits

  • Global Impact: Lead the quality strategy for major worldwide launches.
  • Technical Depth: A role with significant responsibility in a specialized, fast-growing biological portfolio.

Job title

Biological QA Specialist, Qualified Person (QP)

Job type

Experience level

Junior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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