General Responsibility

Plan, review, record, edit and answer questions from the work of analysts in the laboratory and, when appropriate, open OOS or deviations and notify Quality Assurance and plan, create tables, studies SAP introducing in climatic chambers and monitor samples of each batch; according to GMP regulations, operating procedures, Methods of Analysis, Good Laboratory Practices, Protocols and guidelines Stability direct superior; so that the results are consistent, to apply actions to correct deviations, duly recorded anomalous results, the study of stability, keeping the team updated and informed and, ultimately, confirm that batches behave like and registered. All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.

Specific Responsibilities

Organize, supervise and control the work of the team responsible for the analysis and sampling of stability samples in the required timeframes.
Review and approve stability documentation (analytical data).




Creation and review of analytical methods and SOP and control that these procedures are properly implemented and followed by staff.
Create stability protocol and reports.
Ask for stability samples to start the required stability studies.
Assure that all activities of the Laboratory follow approved method, SOP, quality guidelines, etc.
Investigate the cause of deviations and OOS and propose corrective actions under QA Technicians coordination.
Develop no routine activities carried out in the laboratory (including actions arising from deficiencies found in audits, CAPAs, deviations) so they can be finished within the required timeframe.
Make order requests in SAP system for reagents, standards and all the materials and services necessary for activities developed in Quality Control Department.
Provide technical assistance to analysts.
Support Quality Assurance during customer and Authorities inspect

📌 Técnico Estabilidades Control de Calidad (León)
🏢 Chemo
📍 León