Maria Moore-Manzhurin Email and Phone Number

•Assist in the development and revision of SOPs.•Perform SOP review.•Train AOR staff on regulatory compliance and AOR compliance procedures.•Assist in the development, maintenance and implementation of AOR corporate compliance training programs.•Collaboratively interacting with applicable departments to create a positive and effective attitude towards regulatory compliance.•Audit the AOR departmental documentation and activities.

•Led process Improvement of change-control procedures. Established new procedure that provided better control of all changes •Increased Quality awareness raising (Documents’ Quality Control)•Developed and implemented quality procedures •Supervised and approved changes (Change control) and CAPA implementation according to FDA and EU regulations and guidelines requirements•Improved performance by monitoring trends with a KPI Dashboard•Monitored quality assurance system and reported findings to appropriate management•Internal QA auditor•GMP Trainer

A new position in Kamada created and promoted by myself. Duties and responsibilities included:•Increased Quality awareness raising by training production operators•In charge of problem solving and ensuring high quality production process •Led trouble-shooting and brainstorming group during process investigations•Wrote validation protocols and summary reports as applicable to GMP Facilities, Utilities, Automation/Computer Systems and Equipment•Monitored CAPA and change control implementation to promote completion of all tasks in CAPA and change control•Professional presentations: (RCA) Root Cause Analysis of Deviations, Corrective and Preventive actions

•Reviewed production data, laboratory data and charts to ensure high quality production•Monitored physical and microbiological conditions in clean rooms•Led investigations to detect root cause analysis in Laboratory and Manufacturing•Determined an emergency and temporary work orders

•Managed validation team•Checked validation protocols by observing GMP rules•Managed of engineering archives•External and internal audits

•Writing validation protocols (PQ)•Preparing annual reports•Investigation of production irregularities observing GMP rules, acquaintance of production processes and equipment