Quality Assurance Vacancy At Sanofi Egypt

Quality Assurance Vacancy At Sanofi Egypt

Quality Assurance Vacancy At Sanofi Egypt
Quality Assurance Vacancy At Sanofi Egypt

Risk Management & Inspection Readiness QA Senior


  • Contamination Control Strategy (For Sterile):
    • Act as the Contamination Control Subject Matter expert for the site.
    • Lead and follow Annex 1 project, manage the project implementation plan with different cross functional teams in IA.
    • Contamination control strategy leading and ensure its implementation on-site.
    • Maintain the Holistic contamination control strategy up-to-date for sterile facility.
    • Perform the responsibilities of the contamination control SME.
  • Quality Risk Management
    • Execution of quality risk process.
    • Follow up implementation of quality risk assessments master plan.
    • Act as facilitator for risk assessment process on-site.
  • Global Quality Documents Gap analysis
    • Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis
    • Perform gap analysis for the assigned documents.
  • Annex 1 Compliance:
    • Supervising and participation in Annex 1 required gap assessments.
    • Performing of required risk assessments.
    • Creation of Holistic contamination control strategy.
  • Participate in Site Self inspection for GMP related areas among all industrial affairs departments
    • Preparation of an annual plan for internal audit for different departments on yearly basis.
    • Participate in Execution of the plan through conducting self-inspection in different departments.
    • Creation of self-inspection report within the specified timelines.
    • Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.
  • Inspection Readiness (GRIC, SQRs, Inspections and Audits Management).
    • Ensure inspection readiness according to the IR Sanofi handbook.
    • Create satisfactory action plan for the communicated GRIC memos, SQR reports, and received audits or inspections by the concerned area responsible.
  • Suppliers and subcontractors’ Audits
    • Set the annual audit plan for Cairo site.
    • Manage the implementation of the plan and follow it’s closure.
    • Participate in Suppliers and subcontractors’ audits.
    • Documentation of audit reports and follow up of its relevant action plans implementation.


  • 5+ years total experience in Pharmaceutical environment within Quality Assurance/Production.
  • Practical experience in risk assessment processes.
  • Practical experience for different manufacturing processes regulations.
  • Experience in Sterility assurance concepts. “Knowledge of contamination control strategies & Annex 1 requirements is an asset”.


  • Good communication & Presentation skills.
  • Planning & organizing skills
  • Problem solving skills.
  • Report writing skills.
  • Ability to co-ordinate several inter-departmental activities.
  • Good command of MS Word, Excel & Power Point.
  • Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).

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