Tatevik Babayan Email & Phone Number

Tallinn, Harjumaa, Estonia

Armenia

• Working on all relevant SOPs/Policies of conducting clinical trials/BE studies
• Conducting training on all procedures for the conduct of the study
• Overseeing the smooth running of clinical trials/BA studies
• In charge of document management
• Managing research budgets
• Informing participants about study objectives

• Define the Company QMS objectives, assist in QMS risk assessment and strategic direction jointly with Company management;
• Promote and effectively manage the development, implementation, and enhancement of integrated QMS, ISMS and PIMS in line with the requirements of ISO 9001:2015, ISO 27001:2013 and 27701:2019, respectively;
• Assist Technical QA in validation process for EDC or related software solutions
• Manage Quality Assurance department activities;
• Participate in the periodic SOP review process with SMEs according to regulatory requirements
• Oversee the Company’s QMS activities, including establishment and continual improvement of the QMS processes;

Armenia

• Develop, implement, maintain, and communicate the corporate quality strategy, quality annual plan and quality programs throughout the Company
• Design and integrate an effective, necessary and adequate Quality Management System, incorporating relevant SOPs and/or any other documents
• Responsible for CAPA/Deviation Management
• Coordinate activities and lead interactions during regulatory agency inspections
• Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
• Perform and administer external audits according to a predefined audit plan.

Yerevan, Armenia

• Prepare and direct the technical aspects of managing the company in accordance with GxP guidelines
• Development/review/implementation of the Quality Management system/SOPs
• Ensure compliance to protocols, SOPs and regulatory requirements
• Conduct of the GCP investigator sites audits
• Conduct an audit for each bioequivalence study
• Conduct of the TMF/vendors’ audits

Armenia

• Plan and sustain the M&E systems to provide quality information
• Ensure proper and timely implementation of M&E activities
• Document good practice from planning, implementation, monitoring and evaluation of activities.
• Support Proposal development and Reporting
• Develop and adapt strategic plans & proposals to ensure the mission’s objectives are achieved, integrating innovative approaches to M&E activities
• Report writing both in quarterly and annual bases both for the management and donors

Armenia

• Carry out company strategy, under the direction of the Director
• Prepare, edit and oversee the preparation of the tender proposals
• Maintain contacts with Armenian, US and European suppliers
• Draft and solicit content for tender proposals, quotations, etc.
• Respond to requests and refer them to the Director, as necessary
• Conduct e-mail and other correspondence with suppliers and clients on behalf of the Company

• Planning and carrying out trials
• Tracking environmental microorganism development
• Growing microbe cultures
• Collecting samples from a variety of locations
• Recording, analyzing and interpreting data
• Ensuring that data is recorded accurately in accordance to guidelines

Master Of Public Health (Mph), Public Health

Master'S Degree, Ecology

Bachelor'S Degree, Biochemistry