Job Description

This QA Head position for sterile manufacturing. A person should have experience in the Quality system for sterile manufacturing and sterility assurance. A person should have thorough knowledge and understanding of process microbiology and Environmental Monitoring. A person should have exposure to Regulatory Inspection.

This Role will have the following responsibilities but are not limited to:

  1. Responsible for Management of the Environmental Monitoring program
  2. Responsible for Management of Media fill program
  3. Responsible for management of Daily and Overall sterility Assurance activities
  4. Responsible for NVPC Monitoring program
  5. Responsible for Personnel Qualification program for aseptic area
  6. Responsible for Physical monitoring parameter ( Temp/RH/DP/LAF)
  7. Responsible for the Smoke study program
  8. Responsible for Environmental Monitoring excursion Investigation at Site
  9. Any other activities associated with this role

 

Qualifications: M.Sc / B.Pharm / M.Pharm

Experience: 20 to 25 Yrs

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