Senior Quality Officer

• May 2022 - Present

• Sep 2020 - Jun 2022

Regulatory quality assurance activities related with development, implementation and maintaining of quality management systems for pharmaceutical products. Responsible for licensing, certification processes.

• Sep 2015 - Sep 2020

Knowledge in the field of regulatory compliance, mainly with ISO 13485, MDD 93/42, ANVISA GMP for MD 16/2013, SOR/98-282, MDSAP. Initiatives to implement MDSAP, MDR. Organization and accompanying certification audits both internal and external. Preparation for the auditing and conduction of it. Communication with notified bodies. Incident reporting. Change reporting. Organization of audits and their full support. Complaint handling - investigation of root causes, recording of the results. Presentation of QMS to external auditors. Support and provision of QMS throughout the company. Data analysis of QMS. Implementation and upgrading of QMS. Leader of a risk management group. Knowledge of ISO 14971. Development of RMF for medical devices. Preparation and changes evaluation to Technical documentation for medical devices. Leader of a changes management in the field of medical devices at the enterprise. Supplier qualification. Development, updating procedures, Technical file for medical devices. Supervisor of quality management team in the field of medical devices. Internal auditor. CAPA management. Development of corrective and/or preventive actions. Coordination of works and control of their timely implementation. Show less

• Aug 2015 - Sep 2020

seniour specialist at the income management department

• Oct 2012 - Aug 2015

Teacher of English Language

• Jan 2010 - Sep 2010