Plasma Release Manager

Key responsibility :

• Compile and review all documentation related to plasma batch release.
• Manage major and critical deviations related to all processes involved through in plasma supply Chain.
• Timely release of batches in order to meet supply demands.
• and on time closure of deviation investigations.
• Identification of potential trends that may impact to the product, and escalation to Quality Senior Director, ensure that robust investigations are performed and appropriate CAPAs implemented.
• Establish departmental performance objectives and measurements and verifies the creation of metrics, efficiency reports, and key performance indicators.
• Maintains thorough familiarity and ensures compliance with local competent authority regulations, E.U. pharmacopeia, U.S. Food and Drug Administration (FDA) regulations, Standard Operating Procedures, and Current Good Manufacturing Practice (cGMP).
• Manages and develops departmental budgets, and manages expenses and operations within established parameter.
• To have an active involvement in site quality systems, deviations, change controls, SOPs and selfinspections. Actively maintain and promote a cGMP compliant culture, ensuring the compliance with Egyptian Regulation, in accordance to EU and USA requirements and with approved licenses.

Academic experience required :

• Bachelor s Degree in Health-related Sciences
• Post-Graduate Certification in Quality Management.
• 3 years of Experience on Quality system tasks desired.
• Knowledge of cGMP.

Professional experience required :

• Typically requires 8 years of general experience and 3 years of related quality experience. Quality Management Project or technical leadership experience required. Supervisory or management experience essential

Personal skills :

• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor-intensive environment.
• Ability to understand, explain, follow, and enforce SOPs and protocols.
• Ability to plan, communicate and execute activities for the improvement of overall operations.

Languages :

Written and spoken English and Arabic.