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.
Intern QA Engineer testing web and mobile applications, while collaborating with delivery teams at Flutter Entertainment. Responsible for executing and developing tests to ensure product quality.
QA Tester ensuring quality software for mobile applications at JustDice GmbH. Working in a hybrid environment, collaborating closely with development and product teams for continuous improvement.
Staff Quality Engineer leading quality and compliance strategies within a key role at Integra LifeSciences. Driving improvement objectives across multiple design and manufacturing facilities.
QA Engineer focusing on quality assurance in a dynamic environment at BT Group. Collaborating with teams to enhance software reliability and product release confidence.
Senior QA Engineer at Pitch enhancing software testing and QA processes. Collaborating with multiple teams to ensure quality and performance of applications through automated testing.
Software Dev QA Developer at Fortinet running tests on FortiGate products. Collaborating with developers and researching new cybersecurity technologies.
Fortinet is looking for a QA Engineer to execute testing on network security products. The role involves manual and automated testing in a collaborative environment.
Quality Assurance Intern assisting with QA in trial master files and software testing. Working under the Director of Education and Training to learn about QA practices and regulations.
Quality Assurance Engineering Manager leading QA/Testing center of excellence for security solutions. Ensures highest quality of software and hardware products with hands - on leadership in Agile environment.