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QA Documentation Officer

FPi
Cairo, Egypt
Posted 7 years ago
43Applicants for1 open position
  • 29Viewed
  • 1In Consideration
  • 24Not Selected
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Job Details

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Job Description

  • Issuing SOPs (standard operating procedures) for all technical departments.
  • Responsible for documents control distribution and withdraw the obsolete and invalid versions of standard operating procedures.
  • Responsible for making copies of the required BMR and BPR for production.
  • Follow up and perform all the required documents' changes after approval and withdraw all obsolete versions and distribute the new versions.
  • Verify that the documentation system is in place and well maintained.
  • Prepare the approved document list and prepare the document status on regular basis.
  • File & archive the documents such as: deviation reports, internal and external audit reports, complaints & recall reports.
  • Responsible for security & accessibility of all documents available in QA [hard and soft copies].
  • Handling/sharing in investigation processes e.g. deviations.
  • Participate in the preparation and performing internal audits as per schedule.
  • Responsible for handling of Returned finished goods procedures.
  • Participate in the preparation and performing vendor audits as per schedule.
  • Perform any additional QA activities / tasks assigned by QA manager as per work needs.

Job Requirements

Education :

  • Sc. Of Pharmaceutical Science or Science.

Experience :

  • Previous Experience in pharmaceutical industry, from [ 1-4 ] years.

Knowledge :

  • Knowledge of EU-GMP, WHO And ISO Regulations.

Key Success Factors:

  • Good command of English Language and computer skills
  • Time management skills and good communications skills
  • Team work and report writing skills.

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