Вакансия “Head of Quality Assurance Russia and Eurasia“

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An international company has opened a competition for the position of Head of Quality Assurance Russia and Eurasia

Responsibilities:

Development and monitoring KPIs to measure effectiveness of Quality Management System;

Organization of quality audits of local GMP/GDP-related services providers;

Organization of EAEU GMP audits for foreign manufacturing sites, supporting manufacturing sites for preparations to inspections;

Organization of processes for products release, state/random Quality Control, recalls, handling of deviations & complaints, change control, CAPA management;

Interactions with State Authorities with respect to GMP/GDP compliance, reporting of quality deviations, recalls;

Identification areas of improvements and develop strategies to address the areas;

Collection and analyzing data to identify trends and opportunities for improvement;

Creating and distributing of reports with respect to QA KPIs to local management and Regional/Global QA organization;

Host and lead GMP/GDP related competent authority inspections;

Perform or coordinate internal audits of the compliance of the Quality System;

Ensure the market release from approved suppliers based on local regulations ,batch release documentation and transport conditions documentation;

Managing QA employees, setting goals, monitoring of execution;

Organization of creation, implementation and maintenance of Quality Management System including GDP requirements as well as requirements of Corporate Policies and Standards;

Ensure GMP & GDP compliance at the commercial unit and promote the quality culture;

Ensure the distribution traceability of finished products and returns of products commercialized in the country;

Ensure the GDP compliance of the distribution centers;

Ensure that quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary;

Report to Regional Quality and local management any critical quality incident.

Requirements:

5+ years experience in the similar role;

University degree of Pharmacy/Medicine/Chemistry;

Experience in managing a cross functional team;

Outstanding leadership and partnering competences;

Advanced analytic and structured problem solving competences;

Well developed business management, negotiation and customer relationship building skills;

Strong convincing, communication and customer relationship skills;

Solid knowledge and experience of quality legislation, industry standards and guidelines in Russia, Kazakhstan, other CIS with respect to medicines, food supplements, medical devices, cosmetics;

Self-motivated and independent;

Ability to meet deadlines under pressure;

Critical & systems thinking and risks management skills;

Excellent communication skills (verbal and written).

Benefits:

Competitive salary;

Annual bonus;

Medical and life insurance + also for 1 family member;

Meal allowance;

Compensation for transport;

Mobile allowance;

Opportunities for professional development and growth.