Dynamic and results-oriented professional with extensive experience in project management and business analysis, complemented by a solid academic background in engineering on pharmaceutical and IT/CSV process. Skilled in leading cross-functional teams, developing strategic initiatives, and enhancing operational efficiencies. Demonstrated ability to innovate and drive projects to completion within tight deadlines, achieving significant cost savings and process improvements. Adept at problem-solving, communication, and analytical thinking, I am committed to contributing to the success of dynamic companies looking for growth and excellence.
- Administrator of computer systems in Production/Laboratory Quality Control/Packaging departments.
- Collaborated on interdisciplinary teams to develop creative, cost-effective solutions for complex projects.
- Optimized engineering processes by implementing innovative solutions and streamlining workflow.
- Deploy and Join of Computerized Systems
- IT & CSV validation activities for computerized systems
- Management and support for Enterprise Network and Firewall
- Management and implementation of Switches, Servers and Racks
- IT support in site and GMP department expansion projects
- Management and Implementation of Virtual Servers Architecture
- Microsoft Vulnerability Management and Patching of Physical and Virtual Servers
- Support for Global/EMEA projects
- Reduced validation errors by conducting thorough risk assessments and gap analyses.
- Enhanced data quality by implementing efficient validation processes for CSV projects.
- Improved compliance with industry regulations through diligent adherence to CSV guidelines and best practices.
- Managing utilities on computer systems, instrumentation of QC Laboratories, Packaging and Production Departments following FDA CFR 21 Part 1 regulations by verifying upgrades and implementations available for software and instrumentation
- Creating and managing business tools for Department Scheduling management, KPI Track, Purchasing management, Department Capacity; electronic MBR and personal activity management
- Validation of Excel files for analytical activities.
- System Owner of particle and microbiological control systems, content data management via SCADA
- System Owner of computerized and non-computerized systems of production departments and quality control laboratory - System Owner of the automatic sperlating machines for cosmetic and particle controls
- Review and creation of management SOPs of the departments' systems