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QA / Plant Manager - Medical Devices

Cairo, Egypt
Posted 3 years ago
32Applicants for1 open position
  • 32Viewed
  • 4In Consideration
  • 3Not Selected
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Job Details

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Job Description

  • Create a conceptual design for the factory including (production area (clean room)- labs- warehouse -any other related facility) according to MOH, CE, FDA regulations.
  • Deal with Egyptian Drug Authority for all the procedures to acquire the final registration and qualifying the factory for acquiring CE, FDA, and ISO13845
  • Prepare and attend the meetings of any committee related to the design or any technical meeting related to the license from the medical perspective
  • Verify and assure the classification of a medical device according to the latest approved directive from the Egyptian drug authority, EEC, FDA
  • Acquire  CE, FDA certificates for the products  and any other related tasks Prepare the procedures and the files of the related tests of the product
  • Prepare the following files:
    • Product license with Egyptian drug authority
    • Import the machines file and its approvals from MOH or any other governmental entity
    • Sterilization – Irradiation Validation

Job Requirements

  • Bachelor’s Degree in Pharmacy/ Science/biomedical engineering.
  • Able to travel to different locations inside Egypt.
  • Planning and project management skills.
  • Ability to use designing apps.
  • Good communication skills.
  • Aware of the latest versions and updates of the medical directives.
  • Excellent English and computer skills.
  • Previous experience with establishing a medical device factory is a must.

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