Gabriela Brenes Tortós

Execute and implement the quality system area (critical systems) ensuring the compliance with quality regulations ISO13485.

Lead and coordinate the Microbiological validations, CAPA, NCRs (Sterilization, LAL, surface and product cleaning) according to quality needs accomplishing with ISO 13485.

Responsible for Sterile Release.

Management and coordination of internal and external audits. Backroom and front room management.

Preparate and organize the management review.

Coordinate, supervise and approve environmental, water and endotoxin (LAL) monitoring. Microbiology control for cleanroom ISO7 and ISO8

Coordinate the analysis of Bioburden and endotoxins (LAL).

In charge of reviewing the sterilization cycle and its controls.

Document creation, document change management and revision of documentation.

Performed environmental monitoring in clean rooms, bioburden analysis, endotoxin Analysis (LAL),water monitoring and TOC analysis
Analyze sterile and non-sterile product analysis
Sterilization of materials and supplies.
Method validations including creation of protocols and reports.