Stability Studies Technician ( Zamudio )

Stability Studies Technician ( Zamudio )

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 r...