Plasma Release Manager

6 months ago

مصر, Egypt Grifols Egypt for Plasma Derivatives Full time

**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.

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