Alicia is a goal-oriented and customer focused CQV project manager with over 25 years of experience in the pharmaceutical and biotechnology industry.
Alicia has extensive expertise in commissioning, qualification, and validation with comprehensive knowledge and strong skills in engineering, manufacturing operations, start-up/commissioning, quality assurance, construction system turnover, CGMP compliance, risk assessments, auditing and regulatory agency expectations for the life science industry.
Her hands-on experience with international project management, detail planning, and field execution, coupled with her broad knowledge of FDA, EU, and JP regulatory agencies requirements and guidelines make her a substantial asset on any technically complex project.
Her experience in the area of CQV project delivery includes project management, master planning, and project cost/schedule development/tracking, risk assessment, FAT/SAT assistance, commissioning, qualification, validation, training, system turnover/documentation and interfacing with project team members.
- B.S. - Chemical Engineering, University of Puerto Rico
- International Society for Pharmaceutical Engineering (ISPE)
- McGaw, Inc.