Melissa Guzmán

Apasionada, optimista y en aprendizaje constante. Ingeniera en Biotecnología con 6 años de experiencia en la industria farmacéutica, donde día a día sigo teniendo la oporunidad de contribuir a mejorar la calidad de vida de miles de personas.

Boehringer Ingelheim (2021- Current).

Data Integrity Specialist & Computerized System Admin. Responsible for the system administration and for review the execution of DI principles in computerized systems on the site. A Computerized System assessment with third party FDA consultant was developed in 2021 to detect potential vulnerabilities.

Responsible for overseeing computerized lifecycle documentation (VSR, IQ, OQ, DQ URS, PR, commissioning, decommissioning) and to contribute with IT area and Validation area to complies with PMV.

Boehringer Ingelheim (2020-2021).

Administrative specialist of samples in the quality control laboratory. Execution of remediation project in the sample system using Excel. The creation of an inventory system that allowed the improvement in the Exit and Entry sample process was developed.

Boehringer Ingelheim (2018-2020).

Data Integrity & Computerized Systems Trainee. Responsible for the implementation of Data Integrity principles in the QC lab computerized systems in compliance with 21 CFR Part 11. CAPA implementation related with ALCOA+ were achieved on time. A system was developed with a focus on computerized systems and reference substances, making efficient and traceable the protection of information and standards, which allowed the reduction of time and costs for the company.

Diploma- International certification in executive coaching and work team alignment (2021).

Bachelor in Science degree – Biotechnology Engineering Tecnológico de Monterrey (2020).