Alphard Orot, M.S

Quality Assurance Manager  

  • +24 years experience in Quality management in the pharmaceutical

  and biotech industry.

  • Strong background in radiochemistry, organic and analytical chemistry
  • Expertise in Internal Auditing, Method Validations and CMC preparation
  • Excellent working knowledge with different Quality Systems and FDA Guidance

  (i.e. ISO 9001, ISO 14001, 21 CFR 210-212)

  • Familiar with aseptic manipulations, sterility testing and microbial examination

  following USP<71>, <51>, <61> and <62>