Ademar Santos
Senior Cqv Engineer Life Science @CAI
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WORK HISTORY
Senior Cqv Engineer Life Science @CAI
London, GB
As a CQV Engineer in the life science industry, I am dedicated to assisting clients across the UK in ensuring that their pharmaceutical, biotechnology, and medical device facilities, equipment, and processes are fully compliant, safe, and meet all necessary regulatory standards- Currently collaborating with a client on an ambitious biopharmaceutical manufacturing facility project spanning three continents, focused on producing clinical trial batches, handling both Drug Product and Drug Substance systems- Developing User Requirement Specifications (URS), System Impact Assessments (SIA), and other Installation, Operational, and Performance Qualification (IOQ) documentation- Establishing and maintaining detailed schedules and project status reports utilizing MS Project- Overseeing Factory Acceptance Testing (FAT) activities.
EDUCATION
Ibmec
Master of Business Administration - MBA, Investments and Private Banking
Faculdade de Tecnologia SENAI - Toledo, PR
Master of Business Administration - MBA, Industrial Management and Lean Manufacturing
University of California, Riverside
Split-site undergraduate program, Chemical Engineer
New Jersey Institute of Technology
Split-site undergraduate program, Chemical Engineer
University of Colorado Boulder
Academic English Program
Universidade Estadual do Oeste do Paraná
Bachelor of Engineering (B.Eng.), Chemical Engineering
ABOUT ADEMAR SANTOS
I am a Chemical Engineer and MBA in Industrial Management and Lean Manufacturing, with 8+ yrs of experience in pharmaceutical industry, working with development of packaging solutions for sterile and non-sterile products. Familiar with FDA, EMA, ANVISA and other Regulatory Agencies, as well as cGMP and ICH and ISPE guidelines, ASTM, ISO and DIN standards, and quality system regulations for pharmaceuticals. I have developed Black Belt and Lean Six Sigma (LSS) projects working with FMEA, MSA, SPC and PDCA methodology using Minitab, Excel and Visual Basic Programming.Years of academic development coupled with professional experience in a highly regulated environment, gave me strong technical, analytical, and problem-solving skills, which have helped me overcome any unforeseen obstacles and to complete challenging projects. I have always enjoyed keeping my learning curve steep through theoretical and hands-on training. I look forward to working in challenging scenarios with passion and entrepreneurial spirit, which is what motivates me. As a programming enthusiast, I look for new ways to apply technology as troubleshooting in different fields. You can contact me here on LinkedIn or send me an e-mail.Email: a••••••••@hotmail.comPhone:+44••••••••94
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