ABOUT THE JOB:
The position will work closely with cross-functional teams within the organization and will actively contribute to maintaining the quality and reliability of stability data generated in the laboratory.

Mission:
Ensure the proper execution, documentation, review and monitoring of stability studies for allergy immunotherapy pharmaceutical products, guaranteeing compliance with Good Manufacturing Practices (GMP), internal procedures and applicable regulatory requirements.

Main Tasks and Responsibilities:
- Execute stability studies for allergy immunotherapy pharmaceutical products according to approved protocols.
- Monitor samples stored in stability chambers and verify established environmental conditions.
- Prepare, review and update stability study protocols and reports.
- Draft technical documentation associated with stability studies, including analytical results, trend evaluations and conclusions.
- Perform analytical assays and review results, ensuring data integrity and traceability of generated documentation.
- Manage deviations,



incidents and Out of Specification (OOS) results related to stability studies.
- Coordinate shipment, storage and control of stability samples.
- Collaborate with Production, Quality Assurance, Regulatory Affairs and R&D; departments to ensure compliance with stability plans.
- Participate in internal and external audits related to the Quality Control area.
- Maintain updated records, databases and technical files associated with stability activities.
- Ensure compliance with GMP standards, laboratory safety regulations and internal procedures.

Requirements:
Academic Background:
- University Degree in Health Sciences such as Biology, Biochemistry, Pharmacy or Biotechnology.
- Relevant experience within the pharmaceutical industry is required.

Professional Experience:
- Minimum of 2 years of previous experience in Quality Control laboratories within the pharmaceutical industry.
- Previous experience in stability studi

📌 Stability Studies Technician (Zamudio)
🏢 Roxall Medicina España
📍 Zamudio