Alexandra Nerghes

• Responsible for procurement,storage,inventory of investigational and non-investigational products during the clinical trial
• Responsible for understanding the study protocol and the pharmacy manual in order to provide the correct drug administration schedule and doses, according with the study design
• Ensure that the preparation, labeling and dispensing of the investigational product are made in blinded manner to ensure the clinical trial integrity
• Maintain detailed records of drug preparation and dispensing
• Participate in audits and inspections conducted by sponsor or regulatory agencies
• Responsible for reconciliation of IMP and non-IMP and ensuring and all unused or expired drugs are returned or destroyed, according to the study protocol
• Colaborate with principal investigator, study coordinator and study nurses in order to provide the pharmaceutical expertise in drug related issues
• Communicate closely with clinical trial monitor in all matters regarding the pharmacyst role in clinical trial activity
• Make sure that all trainings are made in timely manner by all pharmacist envolved in clinical trial activity

• Performed technical processes required to dispense medications to patients.
• Managed drug and supply inventories.
• Effectively prioritized tasks and organized workflow to increase efficiency.
• Assisted other pharmacy staff with drug inventory, purchasing and receiving
• Responsible for managing drugs from national oncology program and writing all related documents
• Responsible for preparation, conditioning and check-out of infusions, according with local procedures
• Check medical prescription to ensure the prescribed doses are correct, according with ongoing therapeutical protocols
• Checking for drug interaction

● Responsible for preparing and proper implementation of procedures and control methods used for in-process control laboratory, according to ISO 22000 and cGMP

● Initiator of the incidents in QTS, when quality issues are discovered during production and supporting the work done by the site in investigations and implemetation of CAPA's

● Planning and implementation of calibration program, metrological verification and qualification of the equipments from laboratory

● Reviewer of bulk/ finished product batch files; reviewer of master data batch files

● Responsible to review all the records from equipment’s logbooks of in-process control laboratory to ensure that each testing activity is done and documented correctly and according with the internal standards/specifications and to ensure that there are no data integrity issues

● Responsible for sampling in time of bulks, finished products, validation, utilities samples and sending for testing to external laboratories, according with current specifications

● Responsible to coordinate the testing activities for bulk and finished products and making sure that all testing activities are done according to the specifications and in timely manner

● Responsible for preparing sampling plans for raw materials, bulks and finished products

● Planning sanitation tests(aeromicroflora and equipments), according with current monitoring program

● Review and update SOP's

● Responsible of internal training program for In-process control laboratory; completed Train the Trainers program

● Upload data in LIMS

● Reporting directly to Quality Manager, every issue related to laboratory activity

● Performing the activity from IPQA laboratory, according with the approved procedures,on each phase of the manufacturing process and recording the results and the resolution of the control in the equipment notebook and in the batch file of the product.

● Performing in process control for the partial manufacturing of the medicines from clinical trial, according with the authorised procedures

● Sampling activity for IPQA tests, microbiology, control samples, stability samples and for technological validation processes.

● Checking the cleaning status of equipments, making sure that cleaning activities are done correctly, according with current SOP’s

● Upload data in SAP system (results of testing activities, sampling of reference samples and purrified water samples)