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Operation Technical Specialist (Cairo UNI)

Operation Technical Specialist (Cairo UNI)

Grifols Egypt for Plasma DerivativesGiza, EG
19 منذ أيام
الوصف الوظيفي
  • Follow the approved deviation management and CAPA system, involving appropriate stakeholders for investigation and closure.
  • Proactively identify root causes of deviations and implement corrective and preventive actions to reduce their occurrence.
  • Monitor and analyze deviation trends to identify areas for improvement and implement strategies to minimize the number and impact of deviations.
  • Work closely with cross-functional teams to ensure timely closure of deviations, reducing the overall time taken for resolution.
  • Coordinate and oversee the implementation of operational change control processes.
  • Work closely with cross-functional teams to ensure changes are documented, reviewed, and executed efficiently.
  • Identify and lead continuous improvement initiatives in operational processes to enhance efficiency and quality.
  • Maintain and optimize systems used for tracking and managing deviations and change controls.
  • Develop and implement standardized documentation practices to ensure consistency and compliance across all operational processes.
  • Serve as a key liaison between operations and other departments regarding process management.
  • Provide training and guidance to employees on operational compliance and system updates.
  • Compile all information related to the different processes referred to key process indicators established for plasma supply chain areas.
  • Academic experience required

    • Bachelor's degree in Engineering, Health-related Sciences, or a related field.
    • Knowledge of Quality Management Systems.
    • Knowledge of current Good Manufacturing Practices (cGMP)
    • Minimum of 2 years of related experience in GMP Quality Systems.
    • Minimum of 5 years of professional experience in the pharmaceutical, biotech, or regulated manufacturing industries.
    • Experience with GMP regulations, deviation handling, and change control processes.
    • Familiarity with CAPA investigations and operational excellence methodologies.
    • Knowledge of Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
    • Experience with electronic quality management systems such as SAP-QM, TrackWise, Veeva, or similar platforms.
    • Ability to analyze data and generate reports using database management tools.
    إنشاء تنبيه وظيفي لهذا البحث

    Operation Specialist • Giza, EG