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Plasma Release Manager
- Product and Plasma Release SR Manager is responsible for reviewing and compiling batch specific documentation and data for batch release, ensuring compliance with licensed and cGMP requirements.
- Compile and review all documentation related to product and plasma batch release
- Manage major and critical deviations related to all processes involved through in plasma supply chain as well as in the Manufacturing of Plasma-derived products.
- Timely release of batches in order to meet supply demands
- Completion and on time closure of deviation investigations
- Identification of potential trends that may impact to the product, and escalation to Director of Director of Quality, ensure that robust investigations are performed and appropriate CAPA’s 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 Pro
- 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