RA&QA Director \Healthcare

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* Ensuring legal regulation and quality in the markets of medical equipment and pharmaceuticals in Russia and the CIS countries.
• Supporting businesses by obtaining appropriate regulatory approvals and monitoring compliance with Russian legislation and company standards.
* Maintaining the company's quality Program in compliance with all legal standards.
* Support for the internal audit program, conducting production audits in accordance with ISO 13485, warehouse audits in accordance with GWP, and annual due diligence of suppliers.
* Checking the correctness, functionality and effectiveness of all quality processes and procedures.
* Assessment / audit of current and newly developed procedures and systems for compliance with legislation.
* Control of external audits by regulatory authorities, quality audits by an ISO-certified body, clients, etc.
* Monitoring of CAPA and the complaint processing system in Russia and the CIS.
* Organization of the work of the geographically distributed team of the division.

Key result:
• building effective work of the regulatory relations division taking into account changes in legislation, forming a professional team;
• re-registration of the entire product portfolio (more than 15,000 articles, 100 registration certificates);
* registration of 8 new products;
• obtaining a Russian GMP certificate;
• implementation of the Pharma Track and Trace project);
* strict adherence to project budget and time frames.