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Quality Assurance Coordinator (Release & Doc.) - Pfizer




Position summary:
  • Revision of batch records before product release to insure compliance with site procedures.
  • Participate in document control process within PGS Cairo site.
Job Specific technical/Functional/Professional Competencies:
Batch records review and Release activities:
  • Review of batch documentation and assure strict adherence to written procedures.
  • Ensure applying of GMP rules during review of batch documentation.
  • Participate in Creation Printing and Update of master batch records.
  • Batch Record Review and Archiving.
  • Revision of the product results of analysis on QIS.
  • Participate in internal and external audit programs.
  • Routing and Obsoleting SOPs and Documents on PDOCS.
  • Activation, Obsoleting codes on E1 System.
    Document Control:
  • Routing and Obsoleting SOPs and Documents on PDOCS.
  • Review and approval of Master Batch records, Cleaning SOPs and any other GMP documents as required.
  • Participate in deviations investigations.
    Other:
  • Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
  • Active implementation of Notification to Management procedures.
  • Responsibility for compliance with Pfizer Quality Standards.
Experience and Knowledge:
Bachelor degree in Science / pharmaceutical sciences.
Not less than one year in quality operations
Essential Personal Qualifications:
  • Good command of English both written and spoken.
  • Knowledgeable with interpersonal learning.
  • Communication, teaching and coaching skills.
  • Logical way of thinking
  • High analytical skills
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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