Alejandra Mondragón

Biomedical engineer with a specialty in quality systems, with 5 years of experience in the pharmaceutical industry and interest in communication systems and networks.

From 2021 to present at Fresenius Medical Care

Process Validation Engineer

• Completes projects as assigned by the department manager. Able to prioritize responsibilities and execute the projects with clear objectives.
• Generates (redaction) and review validation protocols, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports (full understanding of Product Development life cycle).
• Proficiently develops and performs testing and evaluation of Process validations and Software validations in compliance with Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ, PPQ).
• Evaluates and execute validation/requalification.
• Maintain and assist in stablishing standardized methods and procedures for software, process, HVAC systems and test methods validations and ensure standardized methods are implemented.
• Maintain compliance with applicable GMP Standards, ISO Standards, Local Standard Operating Procedures (SOP’s) and company policies.
• Work on problems with moderate scope where analysis of situation or data requires a review of factors, risk assessment tools (e.g. FMEA) to evaluate the risks and required mitigation plans associated with the applicable equipment, method or product.

January 2021 to August 2021 at Fresenius Medical Care

Production Supervisor

• Supervision of the production process for the manufacture of the Liquid Acid Concentrates product.
• Oversight of the documental compliance and personnel management to ensure the process quality standards and regulations.
• Achievement of daily production targets to meet annual goal.
• Compliance whit GMP, GDP.

2015-2018 Universidad Autonoma de Guadalajara

Bachelors degree in Biomedical Electronic Engineer

2019 Universidad Autonoma de Guadalajara

Quality Systems Speciality