Center Physician

Ensure the proper selection of suitable plasmapheresis donors according to the effective policiesand procedures as well as the as the clinical experience.Observe and confirm compliance of the Center's medical procedures as they affect the safety ofthe donors and the collected plasma.Responsible for the certification, training and performance of the center medical staff as itpertains to the donor assessment and to compliance with the company's policies and procedures.Provide additional necessary training, re-certification and corrective actions for the center'smedical staff, in collaboration with the training department.Perform the required physical examination for donors.Review donor's related documents carefully.Carefully explain the Informed Consent and witness the donor's signature on the form.In a private and confidential setting, discuss the high-risk behavior educational material anddefinitions of high-risk behavior categories in order to provide the donor with the ability to self excludefrom donating.Participate in the notification and counselling of donors found to be positive for variousinfectious disease markers such as HBV, HIV, HCV, syphilis, and other required tests.Management of Donor Adverse Event Reactions and the appropriate level of care.Timely review of accumulated data to confirm established donor suitability, donor safety andproduct safety.Review the accumulated laboratory data of SPE, syphilis and Total Protein results in a timelybasis, as well as the collection records, to determine whether the donor should be deferred forfurther donation.Approve a donor whose SPE results were abnormal for plasmapheresis when normal results areobtainedRecommend changes and improvements to Standard Operating Procedures.Provide education sessions to the center medical staff according to the company's StandardOperating Procedures (SOP).Learn, understand and be independent working with the PDS (Plasma Donor System).Follows all GMP and good documentation practice guidelines.Review the QA reports for timely and appropriate actions on moderate complexity proceduresfor test problems.