Quality Assurance Manager

Responsibilities:

• Implementing scheduled changes in the QMS processes through the development, and approval of documents/local SOPs and the adoption of applicable Global SOPs as applicable;
• Leading the complaint management at LOC level;
• Organization of maintenance, proper operation of the external audit system;
• Preparation, organization and execution of audits of suppliers and wholesalers including the preparation of reports, development of CAPA plan and tracking CAPAs completions;
• Timely development and completion of quality agreements with suppliers, wholesalers, transport companies, etc., including tracking the status;
• Supporting the execution of local batch releases and the management of associated deviations, CAPA, etc.

Core Competencies / Skills:

• Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards;
• Knowledge of requirements of 61st Federal Law about medicine’s circulation;
• Knowledge of requirements of international standards and recommendations on GMP quality processes (WHO, PIC/S, FDA);
• Experience of holding audits and inspections (internal, external, including service providers);
• Higher education in chemistry/chemistry and technology/chemistry and pharmacy/biology/biology and technology/microbiology/pharmacy. Experience of work in QA/QC more than 5 years;
• Advanced level English, including knowledge of specialized terminology;
• Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards;
• More thab 3 years of Experience leading audits (internal, external, including service providers);
• Proficiency in English – Spoken and written.