Plasma Center Manager

Responsibilities:
• Serve as recognized Center Manager for all verbal and/or written correspondence to state Departments of Health and other regulatory agencies, as necessary.
• Direct supervisory responsibilities of the center staff regarding medical processes and donor selection.
• Fulfills all responsibilities as defined by Egyptian Drug Authority (EDA) for “Responsible Person” (RP) of a plasma collection center.
• Selection of suitable plasmapheresis donors through the use of EDA approved Standard Operating Procedure manual, current country guidelines, cGMP, all internal company procedures as well as personal education and experience.
• Observe and confirm compliance of the Center's medical and laboratory procedures as they affect the safety of the donors and the final product and provide feedback to Center Management Team.
• Responsible for the certification, training and performance of the center medical staff as it pertains to the donor assessment and to compliance with GEPD SOP.
• Provide additional necessary training, re-certification and corrective actions for the center's Medical Staff.
• Provide guidance and certification of the center's medical staff regarding the appropriate and confidential counseling to individuals with unacceptable results, and the appropriate level of care during unusual or severe donor reactions.
• Timely review of accumulated data to confirm established donor suitability, donor safety and product safety.
• Recommend changes and improvements to SOPs.
• Provide education sessions to the center medical staff according to the GEPD SOP.
• Learn, understand and be independent working with the PDS (Plasma Donor system) as it relates to the duties and responsibilities of this position.
• Review the QA reports for timely and appropriate actions on moderate complexity procedures for test problems.